Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403351
• Other study ID #: CP-02/04
• Status: Completed
• Start date: October 2006
• Est. completion date: May 2016

Study information

• Verified date: September 2020
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: May 2016
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Australia	Box Hill Hospital (Eastern Health)	Box Hill	Victoria
Australia	Caulfield General Medical Centre	Caulfield	Victoria
Australia	Northern Hospital (Northern Health)	Epping	Victoria
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Monash University	IM Medical Ltd, Melbourne, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

Australia, 

References & Publications (3)

Kotecha D, Flather M, McGrady M, Pepper J, New G, Krum H, Eccleston D. Contemporary predictors of coronary artery disease in patients referred for angiography. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):280-8. doi: 10.1097/HJR.0b013e3283310108. — View Citation

Kotecha D, New G, Collins P, Eccleston D, Krum H, Pepper J, Flather MD. Radial artery pulse wave analysis for non-invasive assessment of coronary artery disease. Int J Cardiol. 2013 Aug 10;167(3):917-24. doi: 10.1016/j.ijcard.2012.03.098. Epub 2012 Apr 4. — View Citation

Kotecha D, New G, Flather MD, Eccleston D, Pepper J, Krum H. Five-minute heart rate variability can predict obstructive angiographic coronary disease. Heart. 2012 Mar;98(5):395-401. doi: 10.1136/heartjnl-2011-300033. Epub 2011 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other cardiovascular events or procedures		1, 2, 5 years
Primary	Extent and severity of angiographic coronary artery disease		cross-sectional
Primary	All-cause death or myocardial infarction		1, 2, 5 years
Primary	All-cause death, MI or need for cardiac surgery		1, 2, 5 years
Secondary	All-cause death		1, 2, 5 years

External Links

•   Study website