Status:
UNKNOWN
Postconditioning in Primary PCI and Direct Stenting
Lead Sponsor:
Sheba Medical Center
Conditions:
Myocardial Infarction
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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 post...
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 tar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00351247
Start Date
July 1 2006
End Date
May 1 2007
Last Update
July 12 2006
Active Locations (1)
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1
Sheba Medical Center
Tel Litwinsky, Israel