Remote Ischemic Postconditioning in Humans

January 11, 2015 updated by: Hospital Universitario Virgen de la Victoria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Procedure: Control group
In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
Experimental: Remote postcondtioning
Patients assigned to remote ischemic postconditioning (randomized controlled trial)
Procedure: Remote ischemic postconditioning
Patients assigned to remote ischemic postconditioning 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Increase of Troponin at 24 Hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Readmission Due to Acute Coronary Syndrome
Time Frame: 12 month
12 month
Cardiovascular Mortality
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Victoria

Collaborators

FUNDACIÓN IMABIS
Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares

Investigators

  • Principal Investigator: Manuel F Jiménez-Navarro, Doctor, Servicio Cardiología, Hospital Universitario Virgen de la Victoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 11, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-0327/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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