Coronary Thromboaspiration and Infarct Size

This study has been terminated.
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: April 3, 2007
Last updated: October 7, 2008
Last verified: October 2008
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 Intervention
Ischemic Heart Disease
Acute Myocardial Infarction
Device: Export Aspiration System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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) [ Time Frame: of end-diastolic volumeof>20% between the acute phase and 6-montcontrol) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Export Aspiration System
    Patients scheduled for emergency angioplasty
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00456066

Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre
Clermont-Ferrand, Auvergne, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Janusz Lipiecki, Pr
  More Information

Responsible Party: Janusz LIPIECKI, CHU Clermont-Ferrand Identifier: NCT00456066     History of Changes
Other Study ID Numbers: CHU63-0018 
Study First Received: April 3, 2007
Last Updated: October 7, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Acute myocardial infarction
Infarct size
Left ventricular remodelling

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases processed this record on May 02, 2016