Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

September 1, 2020 updated by: Ingrid Hopper, Monash University

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

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

665

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital (Eastern Health)
      • Caulfield, Victoria, Australia
        • Caulfield General Medical Centre
      • Epping, Victoria, Australia, 3076
        • Northern Hospital (Northern Health)
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ARM-CAD 1
Cross-sectional analysis using coronary angiogram results
ARM-CAD 2
Prospective cohort for incident cardiovascular events and mortality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extent and severity of angiographic coronary artery disease
Time Frame: cross-sectional
cross-sectional
All-cause death or myocardial infarction
Time Frame: 1, 2, 5 years
1, 2, 5 years
All-cause death, MI or need for cardiac surgery
Time Frame: 1, 2, 5 years
1, 2, 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: 1, 2, 5 years
1, 2, 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Other cardiovascular events or procedures
Time Frame: 1, 2, 5 years
1, 2, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

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

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-02/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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