Preventive Angioplasty in Myocardial Infarction Trial

ISRCTN	ISRCTN73028481
DOI	https://doi.org/10.1186/ISRCTN73028481
Secondary identifying numbers	07/H0703/109

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

Not provided at time of registration

Study website

Contact information

Dr David Wald
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Preventive Angioplasty in Myocardial Infarction Trial: a randomised controlled trial
Study acronym	PRAMI
Study hypothesis	A 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
Condition	Coronary artery disease
Intervention	Six 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 type	Other
Primary outcome measure	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
Secondary outcome measures	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
Overall study start date	14/04/2008
Overall study end date	14/04/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	600
Participant inclusion criteria	Patients (no age limits, either sex) with acute myocardial infarction undergoing a therapeutic angioplasty to the infarct related artery
Participant exclusion criteria	1. Cardiogenic shock 2. Coronary artery bypass graft (CABG)
Recruitment start date	14/04/2008
Recruitment end date	14/04/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wolfson Institute of Preventive Medicine

London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Clinical Operations Manager
Joint R & D Office
Barts and the London Trust/Barts and the London School of Medicine & Dentistry
QM Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom

Website	http://www.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Charity

Bart's and the London Trust (BLT) Charitable Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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