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Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)

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ClinicalTrials.gov Identifier: NCT00213746
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Coronary Arteriosclerosis Heart Failure, Congestive Myocardial Infarction Myocardial Ischemia Myocardial Stunning

Study Design

Study Type : Observational
Estimated Enrollment : 75 participants
Time Perspective: 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.
Study Start Date : October 2003
Estimated Study Completion Date : December 2005

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U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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): NCT00213746

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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213746     History of Changes
Other Study ID Numbers: 2003/011/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Myocardial Stunning
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Signs and Symptoms
Cardiotonic Agents
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