CRISP AMI FOLLOW UP STUDY ver. 1.0, 2 June 2014
Research type
Research Study
Full title
CRISP AMI Follow Up Study - An extended patient follow up of the Multi-centre, Randomized, Controlled Study of Mechanical Left Ventricular Unloading with Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
IRAS ID
160979
Contact name
Tanya Fawcett
Contact email
Sponsor organisation
Maquet -Datascope Corp
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
The purpose of this extended study is to determine if clinical events/outcomes have occurred since the completion of the main CRISP AMI study in 2011. The events of interest are: Death, Resuscitated Cardiac Arrest, Ventricular Arrhythmia requiring defibrillation, New or worsening Congestive heart failure requiring hospitalization and recurrent Myocardial Infarction.
All patients who were consented and randomized in the main CRISP AMI study will be identified and outcomes will be ascertained out to a minimum of 2 years and maximum of 5 years.
The contact details of the patients previously recruited to CRISP AMI will be reviewed and the patient will be contacted by telephone by the Research Nurse. They will discuss the previous study with the patient and ask if they would be happy to take part in the follow up study, comprising a review of their medical records, possible information from their GP and a short questionnaire about their health over the telephone. A Patient Information Leaflet and Consent Form would then be sent to the patient to read and to sign / return to the Research Team.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/1189
Date of REC Opinion
26 Sep 2014
REC opinion
Further Information Favourable Opinion