Coronary Thromboaspiration and Infarct Size

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00456066
First received: April 3, 2007
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00456066

Locations
France
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
Investigators
Principal Investigator: Janusz Lipiecki, Pr
  More Information

No publications provided

Responsible Party: Janusz LIPIECKI, CHU Clermont-Ferrand
ClinicalTrials.gov 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
Thromboaspiration
Infarct size
Left ventricular remodelling

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014