ISRCTN ISRCTN73028481
DOI https://doi.org/10.1186/ISRCTN73028481
Protocol serial number 07/H0703/109
Sponsor Queen Mary University of London (UK)
Funder Bart's and the London Trust (BLT) Charitable Foundation (UK)
Submission date
25/08/2009
Registration date
07/10/2009
Last edited
27/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Wald
Scientific

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePreventive Angioplasty in Myocardial Infarction Trial: a randomised controlled trial
Study acronymPRAMI
Study objectivesA randomised trial among patients with an acute myocardial infarction (AMI) undergoing a therapeutic angioplasty (a procedure to unblock the artery causing the AMI), to determine the value of preventive angioplasty (additional angioplasty to dilate all other narrowed coronary arteries that were not the cause of the AMI but may cause a future infarct) undertaken as an immediate follow-on procedure.
Ethics approval(s)East London and the City Research Ethics Committee approved in December 2007
Health condition(s) or problem(s) studiedCoronary artery disease
InterventionSix hundred patients with AMI will be allocated at random to receive therapeutic angioplasty alone or therapeutic angioplasty plus preventive angioplasty undertaken as an immediate follow-on procedure. Patients will be followed up for an average of 3 years.
Intervention typeOther
Primary outcome measure(s)

All outcomes will be recorded during the period of follow up and analysed 1 year after the last patient is recruited:
1. Death
2. Non-fatal MI
3. Refractory angina

Key secondary outcome measure(s)

All outcomes will be recorded during the period of follow up and analysed 1 year after the last patient is recruited:
1. Repeat revascularisation
2. Complications of angioplasty
3. Angina score
4. EQ510
5. Economic evaluation

Completion date14/04/2012

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration600
Key inclusion criteriaPatients (no age limits, either sex) with acute myocardial infarction undergoing a therapeutic angioplasty to the infarct related artery
Key exclusion criteria1. Cardiogenic shock
2. Coronary artery bypass graft (CABG)
Date of first enrolment14/04/2008
Date of final enrolment14/04/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 19/09/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes