Coronary Thromboaspiration and Infarct Size

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Heart Disease Acute Myocardial Infarction

Keywords

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Acute myocardial infarction Thromboaspiration Infarct size Left ventricular remodelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Export Aspiration System

Patients scheduled for emergency angioplasty

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Janusz Lipiecki, Pr

Role: PRINCIPAL_INVESTIGATOR

Locations

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Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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CHU63-0018

Identifier Type: -

Identifier Source: org_study_id