Coronary Thromboaspiration and Infarct Size
This study has been terminated.
Sponsor:
University Hospital, Clermont-Ferrand
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Detailed Description:
-
Device: Export Aspiration System
Patients scheduled for emergency angioplasty
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
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:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Infarction Myocardial Infarction Coronary Disease Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 16, 2013