Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000786998
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
27/07/2011
Date last updated
15/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiovascular Magnetic Resonance Imaging study assessing myocardial ischemia in patients with end-stage renal disease and renal transplant - evaluation for renal transplant cohort
Scientific title
Study of myocardial ischemia post renal transplant as assessed by Cardiac MRI in patients with end-stage renal disease - evaluation for renal transplant cohort
Secondary ID [1] 262692 0
None
Universal Trial Number (UTN)
U1111-1122-1549
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myocardial ischaemia in patients with renal disease 268394 0
Condition category
Condition code
Cardiovascular 268535 268535 0 0
Coronary heart disease
Renal and Urogenital 270568 270568 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Framingham's risk score at baseline (race, age, smoking history, family history of cardiac disease, cardiac risk factors)
Blood tests at baseline - biochemical markers (hsCRP); markers of fibrosis (MMP); troponin T, BNP and homocysteine levels.
Cardiac MRI at baseline - cine images; Blood oxygen level dependent MRI (BOLD) rest and stress using adenosine 140mcg/kg/min for 3-6 minutes.
These patients will then undergo dobutamine stress echocardiography (40 patients) or coronary angiography (40 patients) at the discretion of their cardiologist or renal physician as part of routine work up for transplant.
Clinic visit at 12 months for repeat bloods. A subset of 50% of these patients who have been transplanted will have follow-up BOLD-MRI imaging performed 3 months after transplant, and delayed enhancement CMR imaging. Final phone follow up at 24 months.
Intervention code [1] 267042 0
Diagnosis / Prognosis
Intervention code [2] 267063 0
Early detection / Screening
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269286 0
Major Adverse Cardiac Events including angina, myocardial infarction, rehospitalisation with cardiac event, cerebrovascular event, heart failure and death assessed by reviewing patients medical records and phone call
Timepoint [1] 269286 0
6, 12 and 24 months
Secondary outcome [1] 279300 0
BOLD, Delayed Enhancement-CMR as predictors of Major Adverse Cardiac Events
Timepoint [1] 279300 0
6, 12 and 24 months
Secondary outcome [2] 279356 0
Troponin T and hsCRP as predictors of Major Adverse Cardiac Events
Timepoint [2] 279356 0
6, 12 and 24 months

Eligibility
Key inclusion criteria
All patients placed on renal transplant waiting list and referred for cardiac assessment, regardless of their symptoms will be recruited in this study. 40 patients who have undergone DSE and 40 patients who have undergone coronary angiography
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent; Extreme Claustrophobia; Implantable cardiac devices and other contra-indications to MRI (i.e. metal in eyes); Asthma or other reversible bronchospasm; Patients on theophylline; Inability to lie flat for 1 hour

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267513 0
Hospital
Name [1] 267513 0
Flinders Medical Centre
Country [1] 267513 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Address
Dept Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country
Australia
Secondary sponsor category [1] 266555 0
None
Name [1] 266555 0
Address [1] 266555 0
Country [1] 266555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269480 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 269480 0
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Ethics committee country [1] 269480 0
Australia
Date submitted for ethics approval [1] 269480 0
02/09/2010
Approval date [1] 269480 0
14/02/2011
Ethics approval number [1] 269480 0
1/10/0380

Summary
Brief summary
This project is designed to assess myocardial ischemia in various populations of patients with renal disease. These cohorts of patients have significant cardiovascular morbidity and mortality. It is believed that apart from epicardial coronary disease, they also have microvascular or small vessel ischemia. Dialysis is thought to be a major contributor in acceleration of their cardiovascular disease, however even after renal transplantation, there cardiovascular morbidity and mortality does not mirror the general population. We are going to assess myocardial ischemia using cardiac MRI and blood oxygen level dependent imaging. This uses intrinsic contrast of deoxy-hemoglobin to assess ischemia. We are going to assess it in patients on dialysis regardless of their cardiovascular symptoms as this group of patients have significant disease despite lack of traditional cardiac symptoms. We are also going to look at patients being evaluated for renal transplant. In this population, we can directly compare this relatively new technique with traditional method of ischemia assessment. We believe this technique will provided added information to already existing imaging modalities as it looks at oxygenation of the myocardium, which precedes development of ischemia. Our third study, evaluates patients after their renal transplant, examining markers that may predict cardiovascular morbidity and mortality in this group. This study is the evaluation for renal transplant cohort and is associated with ACTRN12611000783921 and ACTRN12611000785909
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32917 0
Address 32917 0
Country 32917 0
Phone 32917 0
Fax 32917 0
Email 32917 0
Contact person for public queries
Name 16164 0
Christine Edwards
Address 16164 0
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 16164 0
Australia
Phone 16164 0
+61 8 8201 5656
Fax 16164 0
Email 16164 0
[email protected]
Contact person for scientific queries
Name 7092 0
Professor Joseph Selvanayagam
Address 7092 0
Dept Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country 7092 0
Australia
Phone 7092 0
+61 8 8404 3971
Fax 7092 0
Email 7092 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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