Postconditioning in Primary PCI and Direct Stenting

July 11, 2006 updated by: Sheba Medical Center

Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting

To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sample size: 45 subjects

Site Locations: Sheba medical center

Patients: Patients presenting with an acute MI with onset of symptoms  6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.

Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.

Primary Endpoint:

  • ST segment resolution.
  • Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
  • Infarct size estimation by cardiac enzymes and cardiac MRI.

Secondary endpoints:

  • Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days

Methods:

  • ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.
  • Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.
  • Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.
  • Left ventricular ejection fraction and wall motion score determined by echocardiography.
  • Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.

Follow-up:

  • Follow up at 30 days: Clinical.
  • Clinical Follow up & Cardiac MRI at 90 days.

Study Type

Interventional

Enrollment

45

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

  • Israel
      • Tel Hashomer, Israel
        • Sheba Medical Center

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is > 21 years of age and provides informed consent.
  • Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
  • Eligible to undergo primary PCI.
  • Symptom duration is < 6 hours prior to primary PCI.
  • Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
  • Angiographic: The target lesion in the proximal or middle segment of a native major coronary artery (LAD, RCA or dominant CX).
  • Angiographic: The target lesion should be suitable for PTCA or stenting.
  • Angiographic: The IRA occlusion will be successfully opened by stenting with TIMI 2-3

Exclusion Criteria:

  • Unwillingness to participate.
  • Prior Acute MI
  • Cardiac arrest or Killip score III-IV
  • Women with known pregnancy.
  • Active significant bleeding.
  • Known allergy for aspirin, ticlopidine and clopidogrel, or heparin.
  • Chronic renal failure with creatinine > 2 mg/dl
  • Other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol.
  • Current participation in other trials using investigational drugs or devices.
  • Contraindications to MRI including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ST segment resolution.
Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
Infarct size estimation by cardiac enzymes and cardiac MRI.

Secondary Outcome Measures

Outcome Measure
Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Victor Guetta, MD, Sheba Medical Center
  • Principal Investigator: Jonathan Leor, MD, Neufeld Cardiac Research Center
  • Principal Investigator: Elad Maor, MD, Neufeld Cardiac Research Center

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

July 1, 2006

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria

July 11, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 12, 2006

Last Update Submitted That Met QC Criteria

July 11, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-06-4066-VG-CTIL

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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