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Postconditioning in Primary PCI and Direct Stenting

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00351247
First received: July 11, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose
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.

Condition Intervention
Myocardial Infarction Procedure: Postconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting

Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 45
Study Start Date: July 2006
Estimated Study Completion Date: May 2007
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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351247

Contacts
Contact: Victor Guetta, MD 972-52-6667127 victor.Guetta@health.sheba.gov.il
Contact: Elad Maor, MD 972-52-3691613 elad.maor@gmail.com

Locations
Israel
Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel
Contact: Victor Guetta, MD    972-52-6667127    victor.Guetta@health.sheba.gov.il   
Contact: Elad Maor, MD    972-52-3691613    elad.maor@gmail.com   
Sponsors and Collaborators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00351247     History of Changes
Other Study ID Numbers: SHEBA-06-4066-VG-CTIL
Study First Received: July 11, 2006
Last Updated: July 11, 2006

Keywords provided by Sheba Medical Center:
Myocardial Infarction
Primary PCI
Postconditioning
MRI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017