- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00487812
Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI
October 6, 2008 updated by: University Hospital, Clermont-Ferrand
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63000
- CHU de Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute myocardial infarction,
- Successful coronary angioplasty in the acute phase,
- Absence of heart failure in the acute phase
Exclusion Criteria:
- acute heart failure in the acute phase
- severe ventricular arrhythmias
- contra indications for MRI imaging
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of left ventricular remodelling at 6-month follow-up
Time Frame: at 6-months follow-up
|
at 6-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of overt heart failure
Time Frame: development of overt heart failure
|
development of overt heart failure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lipiecki Janusz, Dr
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 19, 2007
Study Record Updates
Last Update Posted (Estimate)
October 7, 2008
Last Update Submitted That Met QC Criteria
October 6, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Coronary Disease
- Myocardial Infarction
- Infarction
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Ventricular Remodeling
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic Agonists
- Cardiotonic Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Adrenergic beta-1 Receptor Agonists
- Dobutamine
Other Study ID Numbers
- CHU63-0017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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