Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Primary PCI, Postconditioning, MRI
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 postconditioning.
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.
Interventions
PROCEDUREPostconditioning
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days | — |
Countries
Israel
Contacts
Primary ContactVictor Guetta, MD
Backup ContactElad Maor, MD
Outcome results
None listed