Clinical trial NCT00351247: Postconditioning in Primary PCI and Direct Stenting
Official title: Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Primary PCI
Postconditioning
MRI
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: ST segment resolution.
measure: Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
measure: Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary outcomes:
measure: Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Victor Guetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neufeld Cardiac Research Center
name: Jonathan Leor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neufeld Cardiac Research Center
name: Elad Maor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
citation: Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002.