Clinical Trial: Remote Ischemic Postconditioning in Humans

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Remote Ischemic Postconditioning. Can it Prevent Myocardial Injury During Percutaneous Coronary Intervention?

Brief Summary: The aim of this study is to evaluate the phenomenon of remote ischemic post-conditioning in humans. The minor myocardial damage associated with percutaneous revascularization procedures may be attenuated by producing controlled ischemia in the arms immediately after carrying out these procedures (remote ischemic post-conditioning). The justification and design of this clinical trial has been reported: Cardiology. 2011;119(3):164-9.

Detailed Summary:

Percutaneous coronary intervention (PCI) has taken on an important role in the treatment of ischemic heart disease in recent years. However, the beneficial effects of revascularization are partly shadowed by post-reperfusion injury, which accounts for up to half the size of the reperfused myocardial infarct. Several drugs and procedures exist that might protect against this phenomenon. One of the most controversial of these strategies, which has shown promising results in experimental animal models, is remote ischemic post-conditioning. This involves inducing ischemia at a site remote from the heart after an ischemic coronary lesion to reduce the resulting myocardial infarct size.

The myocardial damage produced by ischemia-reperfusion associated with PCI is a known short- and long-term prognostic factor, and is associated with a greater risk of death, myocardial infarction and revascularization during the follow-up.

Our aim is to assess the phenomenon of remote ischemic post-conditioning in patients undergoing PCI, in whom the acute insult on the myocardium is determined by the angioplasty itself. Additionally, we aim to evaluate this phenomenon in a subgroup of diabetic patients, among whom the effectiveness of protective measures against post-reperfusion damage is more questioned.

We have designed a randomized, single-blinded interventional study involving 320 patients (40% diabetics) who are to undergo elective PCI. At the end of the angioplasty procedure, the patients assigned to remote ischemic post-conditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated. In the control group the procedure will be limited to placing a deflated blood-pressu
Sponsor: Hospital Universitario Virgen de la Victoria

Current Primary Outcome: Maximum Increase of Troponin at 24 Hours [ Time Frame: 24 hours ]

Original Primary Outcome: Area under the curve of troponin I and CK-MB [ Time Frame: 24 hours ]

The infarct size will be analyzed from an enzyme curve of troponin I and CK-MB values 0, 8, 16 and 24 hours after the procedure


Current Secondary Outcome:

  • Readmission Due to Acute Coronary Syndrome [ Time Frame: 12 month ]
  • Cardiovascular Mortality [ Time Frame: 12 month ]


Original Secondary Outcome: Major Adverse Cardiovascular Events (MACE) [ Time Frame: 12 month ]

Readmission due to acute coronary syndrome, heart failure or major arrhythmic events and overall and cardiovascular mortality


Information By: Hospital Universitario Virgen de la Victoria

Dates:
Date Received: April 26, 2010
Date Started: February 2009
Date Completion:
Last Updated: January 11, 2015
Last Verified: January 2015