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Evaluation of Myocardial Viability by Means of Low-Dose Dobutamine Gated SPECT (the DOGS Study)
This study has been completed.
Sponsors and Collaborators: University Hospital, Rouen
Bristol-Myers Squibb
GE Healthcare
Fédération Française de Cardiologie
Société Française de Cardiologie
Société Française de Médecine Nucléaire
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213746
  Purpose

Viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. Several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. A combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. However, the value of this combined analysis has not been validated in unselected patients referred for viability assessment.

The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and CABG).

Finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.


Condition
Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Ischemia
Myocardial Stunning

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Failure
Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine tartrate Dobutamine lactobionate
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study.

Further study details as provided by University Hospital, Rouen:

Estimated Enrollment: 75
Study Start Date: October 2003
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population consists with patients with documented coronary artery disease and left ventricular dysfunction (LVEF < 50%)referred to aNuclear Medicine department for myocardial viability assessment

Criteria

Inclusion Criteria:

  • Documented coronary artery disease
  • Left ventricular dysfunction (LVEF < 50%)
  • Patients referred to the Nuclear Medicine department for myocardial viability assessment
  • Sinus Rhythm
  • Acceptance of a 6-month follow-up
  • Signed informed consent

Exclusion Criteria:

  • Recent acute coronary syndrome (< 21 days)
  • Atrial Fibrillation or significant arrhythmias
  • Implanted pacemaker
  • Contra indication to dobutamine
  • Non ischaemic cardiomyopathy
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213746

Locations
Belgium
AZ-VUB
Brussels, Belgium, B 1090
France
University Hospital of Rouen
Rouen, France, 76031
University Hospital of Nancy
Nancy, France, 54037
University Hospital of Caen
Caen, France, 14000
Hopital Européen Georges Pompidou
Paris, France, 75908
CHU de Brest
Brest, France, 29200
Hopital Sud-Francilien
Corbeil, France, 91100
Hopital Avicenne
Bobigny, France, 93009
Sponsors and Collaborators
University Hospital, Rouen
Bristol-Myers Squibb
GE Healthcare
Fédération Française de Cardiologie
Société Française de Cardiologie
Société Française de Médecine Nucléaire
Investigators
Study Chair: Alain Manrique, MD University Hospital, Rouen
Study Director: Pierre-Yves Marie, MD University Hospital of Nancy
Study Director: Philippe Franken, MD Free University of Brussels
  More Information

Publications:
Study ID Numbers: 2003/011/HP
Study First Received: September 13, 2005
Last Updated: June 13, 2008
ClinicalTrials.gov Identifier: NCT00213746  
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Revascularization
Tomography, Emission-Computed, Single-Photon
Dobutamine
Myocardial Stunning
Myocardial Hibernation

Study placed in the following topic categories:
Arterial Occlusive Diseases
Myocardial Stunning
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Dobutamine
Coronary Disease
Necrosis
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 12, 2009