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OpenTrials
Completed

NCT Number: NCT00755469

Post-conditioning to Reduce Infarct Size

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post-conditioning

Procedure

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.

Primary outcomes

  1. Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI

    Time frame: 3 months

Secondary outcomes

  1. The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • Society for Cardiovascular Angiography and Interventions

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2008
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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