Coronary Thromboaspiration and Infarct Size

October 7, 2008 updated by: University Hospital, Clermont-Ferrand

Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.

Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Device: Export Aspiration System

Detailed Description

Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- Auvergne
  - Clermont-Ferrand, Auvergne, France, 63000
    - Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

acute phase of myocardial infarction (>48 hours from the onset of chest pain)
stable hemodynamic conditions
completely occluded infarct related artery

Exclusion Criteria:

heart failure signs in the acute phase
contra indication for MRI or SPECT IMAGING

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

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT Time Frame: by ce-MRI and rest Tc99m-mibi gated SPECT	by ce-MRI and rest Tc99m-mibi gated SPECT

Secondary Outcome Measures

Outcome Measure	Time Frame
Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol) Time Frame: of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)	of end-diastolic volumeof>20% between the acute phase and 6-montcontrol)

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Janusz Lipiecki, Pr

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

June 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)