Coronary Thromboaspiration and Infarct Size

Not Applicable

Terminated

• Conditions: Ischemic Heart Disease; Acute Myocardial Infarction

• Registration Number: NCT00456066
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-07
• Last Update Posted: 2008-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT	by ce-MRI and rest Tc99m-mibi gated SPECT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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