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OpenTrials
Completed

NCT Number: NCT00403351

Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Box Hill Hospital (Eastern Health), Box Hill, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extent and severity of angiographic coronary artery disease

    Time frame: cross-sectional

  2. All-cause death or myocardial infarction

    Time frame: 1, 2, 5 years

  3. All-cause death, MI or need for cardiac surgery

    Time frame: 1, 2, 5 years

Secondary outcomes

  1. All-cause death

    Time frame: 1, 2, 5 years

Other outcomes

  1. Other cardiovascular events or procedures

    Time frame: 1, 2, 5 years

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • IM Medical Ltd, Melbourne
  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2016
First posted
Nov 23, 2006
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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