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
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
-
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.
-
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.