Post-conditioning to Reduce Infarct Size

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00755469

Enrollment

Registered

2008-09-19

Start date

2008-09-30

Completion date

2010-08-31

Last updated

2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Reperfusion injury, Post-Conditioning, Infarct size

Brief 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.

Interventions

PROCEDUREPost-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Infarct size, determined by late-enhancement measurements of the LV using gadolinium contrast with cardiac MRI	3 months

Secondary

Measure	Time frame
The degree of Microvascular Obstruction (MVO), as measured by Cardiac MRI	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026