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

June 17, 2013 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B 1090
        • AZ-VUB
  • France
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Brest, France, 29200
        • CHU de Brest
      • Caen, France, 14000
        • University hospital of Caen
      • Corbeil, France, 91100
        • Hopital Sud-Francilien
      • Nancy, France, 54037
        • University Hospital of Nancy
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou
      • Rouen, France, 76031
        • University Hospital of Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

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, Central Hospital, Nancy, France
  • Study Director: Philippe Franken, MD, Free University of Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003/011/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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