Postconditioning in Primary PCI and Direct Stenting

The recruitment status of this study is unknown because the information has not been verified recently.
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

July 11, 2006
July 11, 2006
July 2006
Not Provided
  • ST segment resolution.
  • Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
  • Infarct size estimation by cardiac enzymes and cardiac MRI.
Same as current
No Changes Posted
Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Same as current
Not Provided
Not Provided
 
Postconditioning in Primary PCI and Direct Stenting
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
Procedure: Postconditioning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
May 2007
Not Provided

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.
Both
21 Years to 80 Years
No
Contact: Victor Guetta, MD 972-52-6667127 victor.Guetta@health.sheba.gov.il
Contact: Elad Maor, MD 972-52-3691613 elad.maor@gmail.com
Israel
 
NCT00351247
SHEBA-06-4066-VG-CTIL
Not Provided
Not Provided
Sheba Medical Center
Not Provided
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
Sheba Medical Center
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP