Clinical trial NCT01113008: Remote Ischemic Postconditioning in Humans
Official title: Remote Ischemic Postconditioning. Can it Prevent Myocardial Injury During Percutaneous Coronary Intervention?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Reperfusion Injury
Keywords: Myocardial Reperfusion Injury/mortality
Coronary angioplasty
Reperfusion
Myocardial Reperfusion Injury/prevention & control
Lead sponsor: Hospital Universitario Virgen de la Victoria
Sponsor class: OTHER
Collaborators: name: FUNDACIÓN IMABIS
name: Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares
First posted: 2010-04-29
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 description: 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-pressure cuff (pressure: 0 mmHg) for 25 minutes.

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 (primary endpoint). Measurements will also be taken of pH and lactate in the baseline sample (0 hours) and at 8 hours, and ultrasensitive C-reactive protein at 0 and 24 hours as a contrasted marker of inflammation in ischemic heart disease.

The follow-up, planned for one year, will seek to determine clinically interesting variables (secondary endpoint), such as readmission due to acute coronary syndrome, heart failure or major arrhythmic events and overall and cardiovascular mortality.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing PCI due to stable angina
2. Patients undergoing PCI due to unstable angina
3. Patients undergoing PCI due NON Q acute myocardial infarction with normal troponin at inclusion moment (less than 1 ng/ml)

Exclusion Criteria:

1. Acute myocardial infarction during the previous two weeks
2. Chronic renal failure with baseline creatinine above 3 mg/dL

4. Collateral circulation of the revascularized artery (Rantrop \>0) 5. Prior treatment with glibenclamide. 6. Inability to receive follow-up, blood test or lack of informed consent.

Primary outcomes:
measure: Maximum Increase of Troponin at 24 Hours
timeFrame: 24 hours
Secondary outcomes:
measure: Readmission Due to Acute Coronary Syndrome
timeFrame: 12 month
measure: Cardiovascular Mortality
timeFrame: 12 month
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
Study officials:
affiliation: Servicio Cardiología, Hospital Universitario Virgen de la Victoria
name: Manuel F Jiménez-Navarro, Doctor
role: PRINCIPAL_INVESTIGATOR
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