Clinical trial NCT00412672: Protective Effect of Coronary Collaterals on Infarct Size in Patients With Acute Myocardial Infarction
Official title: Protective Effect of Coronary Collaterals on Infarct Size in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
contrast echocardiography
collateral circulation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2006-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction undergoing primary PCI as reperfusion therapy of a totally occluded coronary artery.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Bern, Switzerland
name: Christian Seiler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: