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Clinical Trials/NCT00403351
NCT00403351
Completed
Not Applicable

Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.

Monash University4 sites in 1 country665 target enrollmentOctober 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Monash University
Enrollment
665
Locations
4
Primary Endpoint
Extent and severity of angiographic coronary artery disease
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
May 2016
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ingrid Hopper

Senior Lecturer

Monash University

Eligibility Criteria

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

Outcomes

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(1, 2, 5 years)

Study Sites (4)

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