Clinical Outcomes of Angioplasty Postconditioning

May 23, 2019 updated by: Hospices Civils de Lyon

Postconditioning and Functional Recovery After Acute Myocardial Infarction

We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Study Type

Interventional

Enrollment (Actual)

91

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

  • France
      • Lyon, France, 69677
        • Michel Ovize

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion Criteria:

  • Cardiac arrest or cardiogenic shock
  • occlusion of the circumflex coronary artery

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Post-conditioning during angioplasty
Procedure: Postconditioning
Postconditioning during angioplasty
Active Comparator: 2
standard angioplasty
Procedure: standard angioplasty
standard angioplasty without postconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
Time Frame: during 72 hours after angioplasty, and at day 5 to 7
during 72 hours after angioplasty, and at day 5 to 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.
Time Frame: at 6 month
at 6 month

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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

September 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004.364

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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