Post-conditioning to Reduce Infarct Size

Myocardial Infarction Clinical Trial

Official title:

Modification of Reperfusion by "Post-Conditioning" Reduces Infarct Size in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755469
• Other study ID #: opt002
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: December 3, 2013
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: December 2013
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

When angioplasty (PTCA) and stenting of the blood vessels of the heart is the treatment for a Heart Attack, there is damage to the heart muscle that is caused by the sudden opening of the blood vessels. This is called "reperfusion injury". The cell death is due to inflammation and the generation of free radicals.

The primary objective of this study is to determine if post-conditioning(four brief (30 second) PTCA balloon inflations) reduces damage to the heart muscle. This will be measured by heart enzyme tests-CK measurements- and by cardiac MRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age = 18 < 80

• Able to give informed consent

• 100% occlusion of a major epicardial vessel with TIMI 0 Flow

Exclusion Criteria:

• Significant collateral blood flow to the distal vasculature of the occluded vessel.

• Previous CABG

• Previous q-wave myocardial infarction in the same territory

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Post-conditioning
The post-conditioning protocol consists of performing 4, 30-second PTCA balloon occlusions followed by 30 seconds of reperfusion for a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery and flow is restored. Following this protocol the vessel will be stented as part of usual practice for treatment of acute MI.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Society for Cardiovascular Angiography and Interventions

Country where clinical trial is conducted

United States, 

References & Publications (3)

Garcia S, Henry TD, Wang YL, Chavez IJ, Pedersen WR, Lesser JR, Shroff GR, Moore L, Traverse JH. Long-term follow-up of patients undergoing postconditioning during ST-elevation myocardial infarction. J Cardiovasc Transl Res. 2011 Feb;4(1):92-8. doi: 10.10 — View Citation

Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, André-Fouët X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. Epub 2005 Sep 26. — View Citation

Traverse JH, Wang YL, Chavez, IJ, Lesser JR, Pedersen WR, Mirheydar H, Henry TD. Post Conditioning reduces infarct size and improves LV function during acute myocardial infarction. Circulation 2006;114:II-344.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI		3 months	No
Secondary	The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI		3 months	No

External Links

•   The Minneapolis Heart Institute Foundation improves cardiovascular health through clinical research and education