This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Monash University
Collaborator Royal Brompton & Harefield NHS Foundation Trust
Start date October 2006
End date June 2008
Trial size 750 participants
Trial identifier NCT00403351, CP-02/04


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Cross-sectional analysis using coronary angiogram results
Prospective cohort for incident cardiovascular events and mortality

Primary Outcomes

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

Secondary Outcomes

All-cause death
time frame: 1, 2, 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.
Principal investigator Dipak Kotecha, MB ChB PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Monash University.