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| Sponsored by: |
University Hospital, Clermont-Ferrand |
|---|---|
| Information provided by: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00487812 |
Purpose
Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.
| Condition | Intervention |
|---|---|
|
Ischemic Heart Disease Myocardial Infarction |
Procedure: Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Prediction of Left Ventricular Remodelling in Patients Treated by Angioplasty in the Acute of Phase of a First Myocardial Infarction by Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) and at 6-month follow-up. Left ventricular remodelling will be defined as an end-diastolic volume increase of >20% between the two exams. A low dose dobutamine gated Tc-99m-mibi SPECT will be also performed on 5th-6th day. Differences in the infarct size and severity as well as the residual inotrope reserve in the infarct area are expected between groups with and without remodelling.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France, Auvergne | |
| CHU de Clermont-Ferrand | |
| Clermont-Ferrand, Auvergne, France, 63000 | |
| Principal Investigator: | Lipiecki Janusz, Dr | unaffiliated |
More Information
| Responsible Party: | CHU Clermont-Ferrand ( Janusz LIPIECKI ) |
| Study ID Numbers: | CHU63-0017 |
| Study First Received: | June 18, 2007 |
| Last Updated: | October 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00487812 |
| Health Authority: | France: Ministry of Health |
|
Acute myocardial infarction left ventricular remodelling SPECT imaging |
|
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction Dobutamine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Protective Agents Pharmacologic Actions Adrenergic Agonists Pathologic Processes Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents |
