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| Sponsors and Collaborators: |
Monash University IM Medical Ltd |
| Information provided by: | Monash University |
| ClinicalTrials.gov Identifier: | NCT00403351 |
Purpose
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).
| Condition |
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Coronary Artery Disease |
| MedlinePlus related topics: | Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Cohort, Cross-Sectional |
| Official Title: | Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease. |
Serum specifically for future cardiac biomarkers
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | May 2009 |
| Groups/Cohorts |
|
ARM-CAD 1
Cross-sectional analysis using coronary angiogram results
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ARM-CAD 2
Prospective cohort for incident cardiovascular events and mortality
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A number of variables including clinical, biochemical, and enzymatic have been evaluated to see if they add to conventional "risk-reduction" models such as Framingham and if so to understand if they may be used in routine clinical practice.
The aim of this study is to assess several known and a few novel risk-factors (heart rate variability, pulse wave analysis, high-sensitivity CRP and BNP) prior to planned elective coronary angiography (cross-sectional analysis) and in a prospective cohort of high and low-risk patients.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
ARM-CAD 1: Patients attending elective coronary angiography ARM-CAD 2: Participants in ARM-CAD 1 plus volunteers with cardiac risk factors
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dipak Kotecha, MBChB MRCP | +61 3 9903 0950 | dipak.kotecha@med.monash.edu.au |
| Australia, Victoria | |||||
| Box Hill Hospital (Eastern Health) | Recruiting | ||||
| Box Hill, Victoria, Australia, 3128 | |||||
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |||||
| Northern Hospital (Northern Health) | Recruiting | ||||
| Epping, Victoria, Australia, 3076 | |||||
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |||||
| Alfred Hospital | Recruiting | ||||
| Melbourne, Victoria, Australia, 3004 | |||||
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |||||
| Caulfield General Medical Centre | Recruiting | ||||
| Caulfield, Victoria, Australia | |||||
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |||||
| Monash University |
| IM Medical Ltd |
| Principal Investigator: | Dipak Kotecha, MBChB MRCP | Monash University |
| Principal Investigator: | David Eccleston, MBBS FRACP | Monash University and Northern Hospital |
| Principal Investigator: | Henry Krum, Professor | Alfred Hospital / Monash University |
More Information
| Responsible Party: | Monash University ( Dr Dipak Kotecha ) |
| Study ID Numbers: | CP-02/04 |
| First Received: | November 22, 2006 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00403351 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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