Clinical Trial: Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (ERIC-PPCI): A Multicentre Ran

Brief Summary: The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

Detailed Summary: The ERIC-PPCI is a 2000 patient 30 UK site randomised controlled double-blind clinical trial which will investigate whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI). It also includes 2 sub-studies. The Biomarker sub-study will investigate the enzymatic infarct size at 6 months. The Cardiac Magnetic Resonance (CMR) sub-study will investigate infarct size at 6 months. This study is a research collaboration with Aarhus University in Denmark (CONDI2 trial ClinicalTrials.gov Identifier:NCT01857414).
Sponsor: University College, London

Current Primary Outcome: Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rates of cardiac death and HHF at 30 days. [ Time Frame: 30 days ]
  • Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. [ Time Frame: 12 months ]
  • TIMI flow post-PPCI. [ Time Frame: 30 days ]
  • Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). [ Time Frame: One year ]
  • Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) hsTrop T and CK-MB. [ Time Frame: 1 week ]
  • CMR substudy: Cardiac MRI in first week and at 6 months (primary endpoint infarct size at 6 mths). [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: October 20, 2014
Date Started: November 2015
Date Completion: December 2019
Last Updated: May 13, 2016
Last Verified: May 2016