NCT00403351

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
665

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

November 22, 2006

Last Update Submit

September 1, 2020

Conditions

Coronary Artery Disease

Keywords

RiskCoronary artery diseaseHeart Rate variabilityPulse wave analysisBNPCRP

Outcome Measures

Primary Outcomes (3)

  • Extent and severity of angiographic coronary artery disease

    cross-sectional

  • All-cause death or myocardial infarction

    1, 2, 5 years

  • All-cause death, MI or need for cardiac surgery

    1, 2, 5 years

Secondary Outcomes (1)

  • All-cause death

    1, 2, 5 years

Other Outcomes (1)

  • Other cardiovascular events or procedures

    1, 2, 5 years

Study Arms (2)

ARM-CAD 1

Cross-sectional analysis using coronary angiogram results

ARM-CAD 2

Prospective cohort for incident cardiovascular events and mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Adults (18 years or older)
  • Male or Female

You may not qualify if:

  • Acute coronary syndrome
  • Urgent angiography
  • Assessment would constitute harm to patient
  • Informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Box Hill Hospital (Eastern Health)

Box Hill, Victoria, 3128, Australia

Location

Caulfield General Medical Centre

Caulfield, Victoria, Australia

Location

Northern Hospital (Northern Health)

Epping, Victoria, 3076, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (4)

  • 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.

    PMID: 19858725RESULT

  • 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.

    PMID: 22121069RESULT

  • 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.

    PMID: 22483418RESULT

  • 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.

    PMID: 30943979DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum specifically for future cardiac biomarkers

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

May 1, 2016

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

AU(4)