Coronary Thromboaspiration and Infarct Size

University Hospital, Clermont-Ferrand

Status: Terminated

Conditions: Ischemic Heart Disease; Acute Myocardial Infarction

Treatments: Device: Export Aspiration System

Study type: Interventional

Funder types: Other

Identifiers

NCT00456066

CHU63-0018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind