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Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI

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ClinicalTrials.gov Identifier: NCT00487812
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Myocardial Infarction Procedure: Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2004
Primary Completion Date : August 2006
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources


Intervention Details:
    Procedure: Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
    All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)


Primary Outcome Measures :
  1. Development of left ventricular remodelling at 6-month follow-up [ Time Frame: at 6-months follow-up ]

Secondary Outcome Measures :
  1. Development of overt heart failure [ Time Frame: development of overt heart failure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487812


Locations
France
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Lipiecki Janusz, Dr

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janusz LIPIECKI, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00487812     History of Changes
Other Study ID Numbers: CHU63-0017
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: October 2008

Keywords provided by University Hospital, Clermont-Ferrand:
Acute myocardial infarction
left ventricular remodelling
SPECT imaging

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Dobutamine
Technetium Tc 99m Sestamibi
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiopharmaceuticals