Coronary Thromboaspiration and Infarct Size

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Terminated

CT.gov ID

NCT00456066

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Acute Myocardial Infarction	Device: Export Aspiration System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre	Clermont-Ferrand	Auvergne	France	63000