NCT00351247

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 12, 2006

Status Verified

July 1, 2006

First QC Date

July 11, 2006

Last Update Submit

July 11, 2006

Conditions

Myocardial Infarction

Keywords

Myocardial InfarctionPrimary PCIPostconditioningMRI

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days

Interventions

PostconditioningPROCEDURE

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (2)

  • 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.

    PMID: 16186417BACKGROUND

  • 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.

    PMID: 12860564BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Victor Guetta, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Jonathan Leor, MD

    Neufeld Cardiac Research Center

    PRINCIPAL INVESTIGATOR

  • Elad Maor, MD

    Neufeld Cardiac Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Guetta, MD

CONTACT

972-52-6667127victor.Guetta@health.sheba.gov.il

Elad Maor, MD

CONTACT

972-52-3691613elad.maor@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

July 1, 2006

Study Completion

May 1, 2007

Last Updated

July 12, 2006

Record last verified: 2006-07

Locations

IL(1)