Postconditioning in Primary PCI and Direct Stenting

Sheba Medical Center

Status

Unknown

Conditions

Myocardial Infarction

Treatments

Procedure: Postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT00351247

SHEBA-06-4066-VG-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.