Back to resultsCoronary Thromboaspiration and Infarct Size
Primary Purpose
Ischemic Heart Disease, Acute Myocardial Infarction
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Export Aspiration System
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling
Eligibility 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
Sites / Locations
- Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre
Outcomes
Primary Outcome Measures
Infarct size and severity assessed 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)
Full Information
NCT ID
NCT00456066
First Posted
April 3, 2007
Last Updated
October 7, 2008
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT00456066
Brief Title
Coronary Thromboaspiration and Infarct Size
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Thromboaspiration, Infarct size, Left ventricular remodelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Export Aspiration System
Intervention Description
Patients scheduled for emergency angioplasty
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janusz Lipiecki, Pr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Cardiology and Radiology, University Hospital, and Departement of Nuclear Medicine, Jean Perrin Cancer Centre
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
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Coronary Thromboaspiration and Infarct Size
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