Post Cond No Reflow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01208727
First received: September 23, 2010
Last updated: May 7, 2013
Last verified: September 2010
  Purpose

After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.


Condition Intervention
Myocardial Reperfusion Injury
Procedure: postconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Extent of the area of microvascular obstruction [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group


Secondary Outcome Measures:
  • Size of the myocardial infarction [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.


Enrollment: 44
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
22 controls patients without post conditionment
Experimental: Intervention
22 posconditioned patients
Procedure: postconditioning
Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years old,
  • Male or female,
  • Presenting first myocardial infarction, with the beginning of pains < 12 hours,
  • Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on IVA or RCA (not CA).
  • Artery guilty with TIMI flow = 0

Exclusion Criteria:

  • cardiac arrest before the angioplasty,
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Magnetic resonance imaging: contre indication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208727

Locations
France
Hospices Civils de Lyon
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: Pierre CROISILLE, MD Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01208727     History of Changes
Other Study ID Numbers: 2008-504
Study First Received: September 23, 2010
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Myocardial infarction
Postconditioning
Microvascular obstruction
No reflow
MRI

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Reperfusion Injury
Reperfusion Injury
No-Reflow Phenomenon
Wounds and Injuries
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardiomyopathies
Postoperative Complications
Pathologic Processes
Ischemia

ClinicalTrials.gov processed this record on September 14, 2014