Postconditioning in Primary PCI and Direct Stenting

Myocardial Infarction Clinical Trial

Official title:

Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00351247
• Other study ID #: SHEBA-06-4066-VG-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2006
• Last updated: July 11, 2006
• Start date: July 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2006
• Source: Sheba Medical Center
• Contact: Victor Guetta, MD
• Phone: 972-52-6667127
• Email: victor.Guetta[@]health.sheba.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Postconditioning

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, André-Fouët X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. Epub 2005 Sep 26. — View 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. Erratum in: Am J Physiol Heart Circ Physiol. 2004 Jan;286(1):H477. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST segment resolution.
Primary	Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
Primary	Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary	Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days