Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI
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
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedOctober 7, 2008
October 1, 2008
1.7 years
June 18, 2007
October 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of left ventricular remodelling at 6-month follow-up
at 6-months follow-up
Secondary Outcomes (1)
Development of overt heart failure
development of overt heart failure
Interventions
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction,
- Successful coronary angioplasty in the acute phase,
- Absence of heart failure in the acute phase
You may not qualify if:
- acute heart failure in the acute phase
- severe ventricular arrhythmias
- contra indications for MRI imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63000, France
Related Publications (1)
Ernande L, Cachin F, Chabrot P, Durel N, Morand D, Boyer L, Maublant J, Lipiecki J. Rest and low-dose dobutamine Tc-99m-mibi gated-SPECT for early prediction of left ventricular remodeling after a first reperfused myocardial infarction. J Nucl Cardiol. 2009 Jul-Aug;16(4):597-604. doi: 10.1007/s12350-009-9098-5. Epub 2009 May 29.
PMID: 19479315DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lipiecki Janusz, Dr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 19, 2007
Study Start
December 1, 2004
Primary Completion
August 1, 2006
Study Completion
September 1, 2008
Last Updated
October 7, 2008
Record last verified: 2008-10