Clinical Outcomes of Angioplasty Postconditioning

Acute Myocardial Infarction Clinical Trial

Official title:

Postconditioning and Functional Recovery After Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419198
• Other study ID #: 2004.364
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Postconditioning
Postconditioning during angioplasty
• standard angioplasty
standard angioplasty without postconditioning

Locations

Country	Name	City	State
France	Michel Ovize	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Thibault H, Piot C, Staat P, Bontemps L, Sportouch C, Rioufol G, Cung TT, Bonnefoy E, Angoulvant D, Aupetit JF, Finet G, André-Fouët X, Macia JC, Raczka F, Rossi R, Itti R, Kirkorian G, Derumeaux G, Ovize M. Long-term benefit of postconditioning. Circulat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size as measured by cardiac enzymes and MRI at day 5 to 7		during 72 hours after angioplasty, and at day 5 to 7
Secondary	Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.		at 6 month