PESCA version 1

• Research type

  Research Study

• Full title

  UMPIRE Trial sub-study - Polypill Effects on Sub Clinical Atherosclerosis (PESCA): A randomised controlled trial of a cardiovascular polypill treatment strategy compared with usual care on carotid intima-media thickness and central blood pressure

• IRAS ID

  61610

• Contact name

  Simon Thom

• Sponsor organisation

  Imperial College

• Eudract number

  2010-023325-37

• ISRCTN Number

  Not Submitted

• Research summary

  PESCA is a sub-study of the UMPIRE clinical trial which is evaluating a 'polypill' treatment strategy for subjects with established cardiovascular disease or at high risk. All PESCA subjects will have already been recruited to UMPIRE and randomised to taking either a single 'polypill' (comprising low dose aspirin, a cholesterol-lowering statin, and one of two blood pressure lowering medicines) or their usual treatment consisting of similar medication in more than one separate tablets. PESCA will evaluate whether: 1) progression of atherosclerosis (fatty deposits which narrow the arteries and impair blood flow to vital organs); and 2) central systolic blood pressure (the pressure in the body's main artery, the aorta, when the heart pumps out blood), are reduced in 'polypill' recipients compared to those who continue their usual treatment. Atherosclerosis and central blood pressure are both strongly associated with increased risk of heart attacks and stroke. Atherosclerosis will be assessed by ultrasound scanning of the carotid (neck) arteries to look at thickness of the artery walls (carotid intima media thickness - CIMT) and plaques (fatty deposits). Direct measurement of central blood pressure is impractical but it will be estimated using a computerised ??pulsecor? device. This uses an inflatable cuff on the arm but provides a detailed recording of the pressure wave as the cuff is deflated which enables ??pulsecor? to calculate central blood pressure.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/86

• Date of REC Opinion

  11 Jan 2011

• REC opinion

  Further Information Favourable Opinion