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Post Cond No Reflow

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ClinicalTrials.gov Identifier: NCT01208727
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Procedure: postconditioning Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction
Study Start Date : April 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Extent of the area of microvascular obstruction [ Time Frame: 5 days ]
    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 :
  1. Size of the myocardial infarction [ Time Frame: 5 days ]
    Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: September 2010

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

Additional relevant MeSH terms:
Myocardial Infarction
Reperfusion Injury
Myocardial Reperfusion Injury
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomyopathies