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Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403351
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : September 2, 2020
Royal Brompton & Harefield NHS Foundation Trust
IM Medical Ltd, Melbourne
Information provided by (Responsible Party):
Ingrid Hopper, Monash University

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).

Condition or disease
Coronary Artery Disease

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.

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Study Type : Observational
Actual Enrollment : 665 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.
Study Start Date : October 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Cross-sectional analysis using coronary angiogram results
Prospective cohort for incident cardiovascular events and mortality

Primary Outcome Measures :
  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 Outcome Measures :
  1. All-cause death [ Time Frame: 1, 2, 5 years ]

Other Outcome Measures:
  1. Other cardiovascular events or procedures [ Time Frame: 1, 2, 5 years ]

Biospecimen Retention:   Samples Without DNA
Serum specifically for future cardiac biomarkers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403351

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Australia, Victoria
Box Hill Hospital (Eastern Health)
Box Hill, Victoria, Australia, 3128
Caulfield General Medical Centre
Caulfield, Victoria, Australia
Northern Hospital (Northern Health)
Epping, Victoria, Australia, 3076
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
Royal Brompton & Harefield NHS Foundation Trust
IM Medical Ltd, Melbourne
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Principal Investigator: Dipak Kotecha, MB ChB PhD Monash University, Royal Brompton Hospital & University of Birmingham
Principal Investigator: David Eccleston, MBBS FRACP Monash University and Northern Hospital
Principal Investigator: Henry Krum, Professor Alfred Hospital / Monash University
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ingrid Hopper, Senior Lecturer, Monash University Identifier: NCT00403351    
Other Study ID Numbers: CP-02/04
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Keywords provided by Ingrid Hopper, Monash University:
Coronary artery disease
Heart Rate variability
Pulse wave analysis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases