Protective Effect of Coronary Collaterals on Infarct Size in Patients With Acute Myocardial Infarction

June 15, 2015 updated by: University Hospital Inselspital, Berne

The hypothesis of the current proposal is that collateral flow is an important determinant of myocardial protection during an ischemic event. Increased collateral flow for any given area at risk will decrease the myocardial damage caused by the occlusion of the infarct related epicardial artery.

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

Study Overview

Status

Withdrawn

Detailed Description

The hypothesis of the current proposal is that collateral flow is an important determinant of myocardial protection during an ischemic event. Increased collateral flow for any given area at risk will decrease the myocardial damage caused by the occlusion of the infarct related epicardial artery.

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

The two primary endpoints are infarct size as assessed by increase of biochemical cardiac markers and coronary collateral perfusion index (CPI) as obtained by transthoracic MCE.

Extent of LV remodelling, i.e., LV dilatation as assessed by serial assessment of LV dimension by LV angiogram and/or echocardiography, respectively.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with acute myocardial infarction undergoing primary PCI as reperfusion therapy of a totally occluded coronary artery.

Description

Inclusion Criteria:

  • Patients with acute myocardial infarction with electrocardiographic criterion and/or typical history of angina pectoris and planned revascularisation according to the acute myocardial infarction disease management guidelines of the University Hospital Bern. Including both, patients undergoing primary PCI and patients referred for rescue PCI after failed thrombolytic therapy
  • Patients > 18 years old of either sex
  • Patients who have given informed consent to the study

Exclusion Criteria:

  • Patients unable to give informed consent e.g. because of mechanical ventilation
  • Patients with cardiogenic shock
  • Patients with myocardial infarction secondary to occlusion of a recently revascularized vessel (subacute stent thrombosis)
  • Patients with severe arrhythmias
  • Patients whose door-to-balloon time exceeds 120 minutes
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Seiler, Prof., University Hospital Bern, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Study Registration Dates

First Submitted

December 15, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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