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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/NCT00403351
Registration number
NCT00403351
Ethics application status
Date submitted
22/11/2006
Date registered
23/11/2006
Date last updated
2/09/2020
Titles & IDs
Public title
Alternative Risk Markers in Coronary Artery Disease (ARMCAD)
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Scientific title
Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.
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Secondary ID [1]
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CP-02/04
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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:
Coronary Artery Disease
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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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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
ARM-CAD 1 - Cross-sectional analysis using coronary angiogram results
ARM-CAD 2 - Prospective cohort for incident cardiovascular events and mortality
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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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Extent and severity of angiographic coronary artery disease
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Assessment method [1]
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Timepoint [1]
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cross-sectional
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Primary outcome [2]
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All-cause death or myocardial infarction
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Assessment method [2]
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Timepoint [2]
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1, 2, 5 years
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Primary outcome [3]
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All-cause death, MI or need for cardiac surgery
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Assessment method [3]
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0
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Timepoint [3]
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1, 2, 5 years
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Secondary outcome [1]
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All-cause death
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Assessment method [1]
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Timepoint [1]
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1, 2, 5 years
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Eligibility
Key inclusion criteria
- Adults (18 years or older)
- Male or Female
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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
- Acute coronary syndrome
- Urgent angiography
- Assessment would constitute harm to patient
- Informed consent not obtained
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/10/2006
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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
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Actual
1/05/2016
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Sample size
Target
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Accrual to date
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Final
665
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Box Hill Hospital (Eastern Health) - Box Hill
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Recruitment hospital [2]
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Caulfield General Medical Centre - Caulfield
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Recruitment hospital [3]
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Northern Hospital (Northern Health) - Epping
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Recruitment hospital [4]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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- Caulfield
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Recruitment postcode(s) [3]
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3076 - Epping
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Royal Brompton & Harefield NHS Foundation Trust
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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IM Medical Ltd, Melbourne
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Estimating the risk of future cardiovascular events such as death, stroke and myocardial
infarction using traditional risk factors (such as age, gender, smoking, diabetes,
hyperlipidaemia and hypertension) is well accepted in patients with and without existing
cardiovascular disease. These estimates are based on a number of robust observational
studies, including the original Framingham study. While these methods apply reasonably well
on a population level their application to the individual patients is not always
straightforward. In addition, risk charts, such as those published by the Joint British
Societies and American Heart Association, may underestimate risk in certain groups, notably
diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as
much as 50% in some studies).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00403351
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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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Dipak Kotecha, MB ChB PhD
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Address
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Monash University, Royal Brompton Hospital & University of Birmingham
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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/NCT00403351
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