Condition category
Circulatory System
Date applied
24/01/2006
Date assigned
24/01/2006
Last edited
07/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Julie Hila

ORCID ID

Contact details

10/1-3 Funda Pl
Brookvale
Sydney NSW
2100
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G03S1204

Study information

Scientific title

Acronym

Study hypothesis

This study aims to test the effect of modular secondary prevention on total blood cholesterol, heart disease risk factors and knowledge in persons who have had an acute coronary syndrome.

Ethics approval

Approved by the Central Sydney Area Health Services Human Research and Ethics Committee (CRGH) on 21st May 2003 (ref: CH/62/6/2003-021).

Study design

Single blinded, randomised controlled trial with three groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary heart disease and acute coronary syndrome

Intervention

Intervention group will participate in modular prevention including individual risk factor assessment, goal setting and coaching. Control group will continue conventional care by their general practitioner. The standard cardiac rehabilitation group will participate in hospital-based cardiac rehabilitation including six weeks of group exercise and education.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of participants with total blood cholesterol less than 4.5 mmol/l.

Secondary outcome measures

Proportion of participants achieving nationally recommended targets for heart disease risk factors, absolute heart disease risk on the lipid risk score and risk factor knowledge

Overall trial start date

01/01/2004

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute coronary syndrome within 12 months of assessment
2. Refusal of invitation to participate in cardiac rehabilitation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

208

Participant exclusion criteria

Diagnosis of uncontrolled cardiomyopathy, aortic stenosis, arrhythmia, dementia or a terminal illness such as end-stage renal failure

Recruitment start date

01/01/2004

Recruitment end date

01/07/2006

Locations

Countries of recruitment

Australia

Trial participating centre

10/1-3 Funda Pl
Sydney NSW
2100
Australia

Sponsor information

Organisation

National Heart Foundation of Australia

Sponsor details

Research Division
411 King Street
West Melbourne VIC
3003
Australia

Sponsor type

Charity

Website

http://www.heartfoundation.com.au

Funders

Funder type

Charity

Funder name

National Heart Foundation of Australia Grant-in-Aid (G03S1204) and a Postgraduate Clinical Research Scholarship for Julie Hila (PC03S1258).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in
1. http://www.ncbi.nlm.nih.gov/pubmed/16762079
2. http://www.ncbi.nlm.nih.gov/pubmed/18801781

Publication citations

  1. Redfern J, Ellis E, Briffa T, Freedman SB, Modular prevention of heart disease following acute coronary syndrome (ACS) [ISRCTN42984084]., BMC Cardiovasc Disord, 2006, 6, 26, doi: 10.1186/1471-2261-6-26.

  2. Redfern J, Briffa T, Ellis E, Freedman SB, Choice of secondary prevention improves risk factors after acute coronary syndrome: 1-year follow-up of the CHOICE (Choice of Health Options In prevention of Cardiovascular Events) randomised controlled trial., Heart, 2009, 95, 6, 468-475, doi: 10.1136/hrt.2008.150870.

Additional files

Editorial Notes