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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
GE Healthcare
Fédération Française de Cardiologie
Société Française de Cardiologie
Société Française de Médecine Nucléaire
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213746
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

September 13, 2005
June 17, 2013
October 2003
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Complete list of historical versions of study NCT00213746 on ClinicalTrials.gov Archive Site
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Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)
Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study.

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Coronary Arteriosclerosis
  • Heart Failure, Congestive
  • Myocardial Infarction
  • Myocardial Ischemia
  • Myocardial Stunning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2005
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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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00213746
2003/011/HP
No
University Hospital, Rouen
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 University Hospital, Nancy
Study Director: Philippe Franken, MD Free University of Brussels
University Hospital, Rouen
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP