Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00403351
• Lead Sponsor: Monash University

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).

Detailed Description

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2008-06
• Study Completion: 2016-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 665

Inclusion Criteria

• Adults (18 years or older)
• Male or Female

Exclusion Criteria

• Acute coronary syndrome
• Urgent angiography
• Assessment would constitute harm to patient
• Informed consent not obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent and severity of angiographic coronary artery disease	cross-sectional
All-cause death or myocardial infarction	1, 2, 5 years
All-cause death, MI or need for cardiac surgery	1, 2, 5 years

Secondary Outcome Measures

Name	Time	Method
All-cause death	1, 2, 5 years

Trial Locations

Locations (4)

Caulfield General Medical Centre; 🇦🇺 Caulfield, Victoria, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Box Hill Hospital (Eastern Health); 🇦🇺 Box Hill, Victoria, Australia

Northern Hospital (Northern Health); 🇦🇺 Epping, Victoria, Australia