Post Cond No Reflow

Myocardial Reperfusion Injury Clinical Trial

Official title:

The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208727
• Other study ID #: 2008-504
• Status: Completed
• Phase: N/A
• First received: September 23, 2010
• Last updated: May 7, 2013
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2010
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Myocardial Infarction
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Procedure:
• postconditioning
Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of the area of microvascular obstruction	Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group	5 days	Yes
Secondary	Size of the myocardial infarction	Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.	5 days	Yes