Clinical Outcomes of Angioplasty Postconditioning - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00419198

Purpose

We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Condition	Intervention
Acute Myocardial Infarction	Procedure: Postconditioning Procedure: standard angioplasty

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Postconditioning and Functional Recovery After Acute Myocardial Infarction

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Infarct size as measured by cardiac enzymes and MRI at day 5 to 7 [ Time Frame: during 72 hours after angioplasty, and at day 5 to 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month. [ Time Frame: at 6 month ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Post-conditioning during angioplasty	Procedure: Postconditioning Postconditioning during angioplasty
2: Active Comparator standard angioplasty	Procedure: standard angioplasty standard angioplasty without postconditioning

Detailed Description:

Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion Criteria:

Cardiac arrest or cardiogenic shock
occlusion of the circumflex coronary artery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419198

Locations

France
Michel Ovize
Lyon, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

michel Ovize, MD

Hospices Civils de Lyon

More Information

Responsible Party:	Hospices Civils de Lyon ( Michel Ovize, Pr. )
Study ID Numbers:	2004.364
Study First Received:	January 5, 2007
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00419198
Health Authority:	France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:

Ischemia
Reperfusion
Myocardial infarction
Postconditioning

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009