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Alternative Risk Markers in Coronary Artery Disease (ARMCAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
IM Medical Ltd, Melbourne
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier:
NCT00403351
First received: November 22, 2006
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Extent and severity of angiographic coronary artery disease [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
  • All-cause death or myocardial infarction [ Time Frame: 1, 2, 5 years ] [ Designated as safety issue: No ]
  • All-cause death, MI or need for cardiac surgery [ Time Frame: 1, 2, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause death [ Time Frame: 1, 2, 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Other cardiovascular events or procedures [ Time Frame: 1, 2, 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum specifically for future cardiac biomarkers


Estimated Enrollment: 750
Study Start Date: October 2006
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
ARM-CAD 1
Cross-sectional analysis using coronary angiogram results
ARM-CAD 2
Prospective cohort for incident cardiovascular events and mortality

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403351

Locations
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
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
  More Information

Additional Information:
Publications:
Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT00403351     History of Changes
Other Study ID Numbers: CP-02/04
Study First Received: November 22, 2006
Last Updated: May 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Monash University:
Risk
Coronary artery disease
Heart Rate variability
Pulse wave analysis
BNP
CRP

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014