Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00487812
First received: June 18, 2007
Last updated: October 6, 2008
Last verified: October 2008
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Development of left ventricular remodelling at 6-month follow-up [ Time Frame: at 6-months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Development of overt heart failure [ Time Frame: development of overt heart failure ] [ Designated as safety issue: Yes ]

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)
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional 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
Study First Received: June 18, 2007
Last Updated: October 6, 2008
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014