Clinical trial NCT00403351: Alternative Risk Markers in Coronary Artery Disease (ARMCAD)
Official title: Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Risk
Coronary artery disease
Heart Rate variability
Pulse wave analysis
BNP
CRP
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: IM Medical Ltd, Melbourne
First posted: 2006-11-23
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARM-CAD 1: Patients attending elective coronary angiography ARM-CAD 2: Participants in ARM-CAD 1 plus volunteers with cardiac risk factors

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.

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

Primary outcomes:
measure: Extent and severity of angiographic coronary artery disease
timeFrame: cross-sectional
measure: All-cause death or myocardial infarction
timeFrame: 1, 2, 5 years
measure: All-cause death, MI or need for cardiac surgery
timeFrame: 1, 2, 5 years
Secondary outcomes:
measure: All-cause death
timeFrame: 1, 2, 5 years
Other outcomes:
measure: Other cardiovascular events or procedures
timeFrame: 1, 2, 5 years
Locations:
city: Box Hill
country: Australia
facility: Box Hill Hospital (Eastern Health)
state: Victoria
city: Caulfield
country: Australia
facility: Caulfield General Medical Centre
state: Victoria
city: Epping
country: Australia
facility: Northern Hospital (Northern Health)
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash University, Royal Brompton Hospital & University of Birmingham
name: Dipak Kotecha, MB ChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University and Northern Hospital
name: David Eccleston, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred Hospital / Monash University
name: Henry Krum, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: Kotecha D, Flather MD, Atar D, Collins P, Pepper J, Jenkins E, Reid CM, Eccleston D; Alternative Risk Markers in Coronary Artery Disease (ARM-CAD) Study. B-type natriuretic peptide trumps other prognostic markers in patients assessed for coronary disease. BMC Med. 2019 Apr 3;17(1):72. doi: 10.1186/s12916-019-1306-9.