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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01842568
Registration number
NCT01842568
Ethics application status
Date submitted
17/04/2013
Date registered
29/04/2013
Date last updated
13/03/2023
Titles & IDs
Public title
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
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Scientific title
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
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Secondary ID [1]
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VISION Cardiac Surgery
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vascular Death
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Myocardial Infarction
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Stroke
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Cardiac Surgery
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All-cause mortality at 30-days after surgery
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Assessment method [1]
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All-cause mortality at 30-days after surgery
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Timepoint [1]
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30 days after surgery
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Primary outcome [2]
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Myocardial injuries that were not identified clinically during the first 5 days after surgery
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Assessment method [2]
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Myocardial injuries that were not identified clinically during the first 5 days after surgery
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Timepoint [2]
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5 days after surgery
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Primary outcome [3]
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Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
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Assessment method [3]
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Major vascular complications at 30 days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)
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Timepoint [3]
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30 days after surgery
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Primary outcome [4]
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Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
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Assessment method [4]
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Major vascular complications at 1-year after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)
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Timepoint [4]
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1 year after surgery
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Secondary outcome [1]
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Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device
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Assessment method [1]
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Major vascular complications at 30-days after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device)
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Timepoint [1]
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30 days after surgery
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Secondary outcome [2]
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Total mortality
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Assessment method [2]
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Total mortality
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Timepoint [2]
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30 days after surgery
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Secondary outcome [3]
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Total mortality
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Assessment method [3]
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Total mortality
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Timepoint [3]
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1 year after surgery
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Secondary outcome [4]
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Vascular mortality
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Assessment method [4]
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death due to vascular cause
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Timepoint [4]
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30 days after surgery
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Secondary outcome [5]
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Vascular mortality
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Assessment method [5]
0
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death due to vascular cause
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Timepoint [5]
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1 year after surgery
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Secondary outcome [6]
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Myocardial infarction
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Assessment method [6]
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Myocardial infarction
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Timepoint [6]
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30 days after surgery
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Secondary outcome [7]
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Myocardial infarction
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Assessment method [7]
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Myocardial infarction
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Timepoint [7]
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1 year after surgery
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Secondary outcome [8]
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Non-fatal cardiac arrest
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Assessment method [8]
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Non-fatal cardiac arrest
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Timepoint [8]
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30 days after surgery
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Secondary outcome [9]
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Non-fatal cardiac arrest
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Assessment method [9]
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Non-fatal cardiac arrest
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Timepoint [9]
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1 year after surgery
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Secondary outcome [10]
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Stroke
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Assessment method [10]
0
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Stroke
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Timepoint [10]
0
0
30 days after surgery
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Secondary outcome [11]
0
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Stroke
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Assessment method [11]
0
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Stroke
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Timepoint [11]
0
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1 year after surgery
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Secondary outcome [12]
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Implantation of mechanical assist device
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Assessment method [12]
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Implantation of mechanical assist device
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Timepoint [12]
0
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30 days after surgery
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Secondary outcome [13]
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Implantation of mechanical assist device
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Assessment method [13]
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Implantation of mechanical assist device
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Timepoint [13]
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1 year after surgery
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Secondary outcome [14]
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Cardiac transplant
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Assessment method [14]
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Cardiac transplant
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Timepoint [14]
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30 days after surgery
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Secondary outcome [15]
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Cardiac transplant
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Assessment method [15]
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Cardiac transplant
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Timepoint [15]
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1 year after surgery
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Secondary outcome [16]
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Repeat cardiac revascularization procedures
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Assessment method [16]
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Repeat cardiac revascularization procedures
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Timepoint [16]
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30 days after surgery
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Secondary outcome [17]
0
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Repeat cardiac revascularization procedures
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Assessment method [17]
0
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Repeat cardiac revascularization procedures
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Timepoint [17]
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1 year after surgery
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Secondary outcome [18]
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Congestive heart failure
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Assessment method [18]
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Congestive heart failure
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Timepoint [18]
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30 days after surgery
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Secondary outcome [19]
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Congestive heart failure
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Assessment method [19]
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Congestive heart failure
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Timepoint [19]
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1 year after surgery
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Secondary outcome [20]
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New atrial fibrillation
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Assessment method [20]
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New clinically important atrial fibrillation
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Timepoint [20]
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30 days after surgery
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Secondary outcome [21]
0
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New atrial fibrillation
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Assessment method [21]
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New clinically important atrial fibrillation
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Timepoint [21]
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1 year after surgery
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Secondary outcome [22]
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Pulmonary embolus
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Assessment method [22]
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Pulmonary embolus
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Timepoint [22]
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30 days after surgery
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Secondary outcome [23]
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Pulmonary embolus
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Assessment method [23]
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Pulmonary embolus
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Timepoint [23]
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1 year after surgery
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Secondary outcome [24]
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Deep venous thrombosis
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Assessment method [24]
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Deep venous thrombosis
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Timepoint [24]
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30 days after surgery
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Secondary outcome [25]
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Deep venous thrombosis
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Assessment method [25]
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Deep venous thrombosis
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Timepoint [25]
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1 year after surgery
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Secondary outcome [26]
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Major bleeding
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Assessment method [26]
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Major bleeding
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Timepoint [26]
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30 days after surgery
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Secondary outcome [27]
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Major bleeding
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Assessment method [27]
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Major bleeding
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Timepoint [27]
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1 year after surgery
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Secondary outcome [28]
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New dialysis
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Assessment method [28]
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New dialysis
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Timepoint [28]
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30 days after surgery
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Secondary outcome [29]
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New dialysis
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Assessment method [29]
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New dialysis
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Timepoint [29]
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1 year after surgery
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Secondary outcome [30]
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Infection
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Assessment method [30]
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Infection (including sternal, sepsis, pneumonia)
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Timepoint [30]
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30 days after surgery
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Secondary outcome [31]
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Infection
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Assessment method [31]
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Infection (including sternal, sepsis, pneumonia)
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Timepoint [31]
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1 year after surgery
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Secondary outcome [32]
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Re-hospitalization for a vascular reason
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Assessment method [32]
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Re-hospitalization for a vascular reason
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Timepoint [32]
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30 days after surgery
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Secondary outcome [33]
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Re-hospitalization for a vascular reason
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Assessment method [33]
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Re-hospitalization for a vascular reason
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Timepoint [33]
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1 year after surgery
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Secondary outcome [34]
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Chronic incisional pain
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Assessment method [34]
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Chronic incisional pain
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Timepoint [34]
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30 days after surgery
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Secondary outcome [35]
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Chronic incisional pain
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Assessment method [35]
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Chronic incisional pain
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Timepoint [35]
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1 year after surgery
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Secondary outcome [36]
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Frailty
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Assessment method [36]
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Frailty assessed by PRISMA-7 questionnaire
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Timepoint [36]
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30 days after surgery
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Secondary outcome [37]
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Frailty
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Assessment method [37]
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Frailty assessed by PRISMA-7 questionnaire
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Timepoint [37]
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1 year after surgery
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Eligibility
Key inclusion criteria
1. Age = 18 years.
2. Patients who have undergone cardiac surgery. This includes coronary artery bypass
grafting and all open heart procedures such as valvular repairs/replacement.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Previously enrolled in the VISION Cardiac Surgery Study.
2. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent
pacemaker or defibrillator implantation.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
15989
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Brazil
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State/province [2]
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Rio Grande Do Sul
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Country [3]
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Brazil
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State/province [3]
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RS
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Country [4]
0
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Brazil
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State/province [4]
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São Paulo
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Country [5]
0
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Canada
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State/province [5]
0
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Ontario
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Country [6]
0
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China
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State/province [6]
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XinJiang
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Country [7]
0
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Hong Kong
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State/province [7]
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Hong Kong, SAR
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Country [8]
0
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Italy
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State/province [8]
0
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Bari
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Country [9]
0
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Italy
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State/province [9]
0
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Milan
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Country [10]
0
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Malaysia
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State/province [10]
0
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Kuala Lumpur
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Country [11]
0
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Poland
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State/province [11]
0
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Gdansk
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Country [12]
0
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Russian Federation
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State/province [12]
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Kemerovo
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Country [13]
0
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Russian Federation
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State/province [13]
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Novosibirsk
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Country [14]
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Spain
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State/province [14]
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Barcelona
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Country [15]
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United Kingdom
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State/province [15]
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Essex
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Country [16]
0
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United Kingdom
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State/province [16]
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Lancashire
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Country [17]
0
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United Kingdom
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State/province [17]
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Merseyside
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Country [18]
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United Kingdom
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State/province [18]
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Edinburgh
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Country [19]
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United Kingdom
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State/province [19]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Population Health Research Institute
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Abbott Diagnostics Division
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although
heart surgery provides important survival benefits, it is associated with potential major
complications such as death, stroke, and heart attack. There is promising evidence that
measurement of heart injury markers after surgery will identify patients at risk of death or
major complications.
This study will determine the current incidence of major complications in a representative
sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current
burden of complications will inform clinicians, administrators, government and granting
agencies about resources required to address the problem. This study will also establish the
role of measuring heart injury markers to identify important heart injury after heart surgery
and the proportion that would go undetected without routine heart injury marker monitoring.
This information will facilitate further studies of timely interventions. In summary, the
VISION Cardiac Surgery Study addresses fundamental questions that will have profound public
health implications given the millions of adults worldwide who undergo heart surgery
annually.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01842568
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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P.J. Devereaux, MD, PhD
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Address
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McMaster University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01842568
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