Clinical Trial: Effect of RIC 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-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Multinational Multicentre Randomise

Brief Summary: The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year in patients presenting with ST-elevation Myocardial Infarction and undergoing primary percutaneous coronary intervention. This will be done in a multinational investigator-driven, multi-centre, randomised, controlled, single-blind, parallel assignment, prospective clinical efficacy trial.

Detailed Summary:

Coronary heart disease (CHD) is the leading cause of death in Denmark and Europe, accounting for 1.92 million deaths in Europe per year: over one in five men (21%) and one in five women (22%) die from CHD.

Patients presenting with a ST-elevation Myocardial Infarction (STEMI)have despite advanced treatment with primary percutaneous coronary intervention (pPCI) a significant mortality and morbidity at one year with 17.4% of patients dying from a cardiovascular cause or being hospitalised from heart failure.

Remote Ischaemic Conditioning (RIC) applied at the time of myocardial reperfusion can reduce myocardial infarct size, confirming the existence of myocardial reperfusion injury. In this respect, RIC has been shown to limit myocardial infarct size and preserve cardiac function in STEMI patients undergoing pPCI.

RIC is performed in the ambulance during transport to the PCI unit by cycles of inflations of a blood pressure cuff to induce four 5-minute cycles of limb ischaemia and reperfusion. The method is virtually cost-free non-pharmacological and non-invasive therapeutic strategy.

Hypothesis:

RIC followed by pPCI improves clinical outcomes in STEMI patients when compared to STEMI controls undergoing standard pPCI evaluated one year post PCI.

Trial Design and aim:

Multinational investigator-driven, multi-centre, randomized, controlled, single-blind (Outcomes Assessor), parallel assignment, prospective clinical efficacy trial. A total of 4300 patients are to be included over a 36 months period.

Overall primary objective To determin
Sponsor: Aarhus University Hospital

Current Primary Outcome: Cardiac mortality [ Time Frame: One year ]

Cardiac mortality and hospitalisation for heart failure at one year


Original Primary Outcome: Cardiovascular mortality [ Time Frame: One year ]

Cardiovascular mortality and hospitalisation for heart failure at one year


Current Secondary Outcome:

  • Myocardial infarct size [ Time Frame: 72 hours ]
    Myocardial infarct size at day 3 (72 hours area under curve serum troponin T)
  • Left ventricular function [ Time Frame: Three months ]
    Left ventricular function on day three and three months post pPCI (Echocardiography)
  • Prognosis [ Time Frame: One year ]
    Re-infarction, stroke and revascularisation at one year
  • Acute kidney injury [ Time Frame: 48-72 hours ]
    Changes in Serum Creatinine


Original Secondary Outcome:

  • Myocardial infarct size [ Time Frame: 72 hours ]
    Myocardial infarct size at day 3 (72 hours area under curve serum troponin T)
  • Left ventricular function [ Time Frame: Three months ]
    Left ventricular function on day three and three months post pPCI (Echocardiography)
  • Prognosis [ Time Frame: One year ]
    Re-infarction, stroke and revascularisation at one year


Information By: University of Aarhus

Dates:
Date Received: May 15, 2013
Date Started: November 2013
Date Completion: December 2017
Last Updated: October 25, 2016
Last Verified: October 2016