Coronary ArteriosclerosisNCT00213746
Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)
An observational study of Coronary Arteriosclerosis and Heart Failure, Congestive, run by University Hospital, Rouen at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction
- How many people
- 75 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2003to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Recent acute coronary syndrome (< 21 days)
- Atrial Fibrillation or significant arrhythmias
- Implanted pacemaker
- Contra indication to dobutamine
- Non ischaemic cardiomyopathy
- Pregnancy
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites
Hopital Avicenne
Bobigny, 93009
CHU de Brest
Brest, 29200
University Hospital of Caen
Caen, 14000
Hopital Sud-Francilien
Corbeil, 91100
University Hospital of Nancy
Nancy, 54037
Hopital Européen Georges Pompidou
Paris, 75908
University Hospital of Rouen
Rouen, 76031
About this study
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.
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.
- Conditions
- Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Ischemia, Myocardial Stunning
- Keywords
- Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Revascularization, Tomography, Emission-Computed, Single-Photon, Dobutamine, Myocardial Stunning, Myocardial Hibernation
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Myocardial Infarction, Myocardial Ischemia, Myocardial Stunning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, GE Healthcare, Fédération Française de Cardiologie, Société Française de Cardiologie, Société Française de Médecine Nucléaire
- Responsible party
- Sponsor
- Investigators
- Alain Manrique, MD, Study chair, University Hospital, RouenPierre-Yves Marie, MD, Study director, Central Hospital, Nancy, FrancePhilippe Franken, MD, Study director, Free University of Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213746
- Sponsor's protocol ID
- 2003/011/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8. doi: 10.1016/s0735-1097(02)01726-6.
PubMed 11923039Everaert H, Vanhove C, Franken PR. Effects of low-dose dobutamine on left ventricular function in normal subjects as assessed by gated single-photon emission tomography myocardial perfusion studies. Eur J Nucl Med. 1999 Oct;26(10):1298-303. doi: 10.1007/s002590050586.
PubMed 10541828Everaert H, Vanhove C, Franken PR. Effect of beta-blockade on low-dose dobutamine-induced changes in left ventricular function in healthy volunteers: assessment by gated SPET myocardial perfusion scintigraphy. Eur J Nucl Med. 2000 Apr;27(4):419-24. doi: 10.1007/s002590050525.
PubMed 10805115Leoncini M, Sciagra R, Maioli M, Bellandi F, Marcucci G, Sestini S, Chiocchini S, Dabizzi RP. Usefulness of dobutamine Tc-99m sestamibi-gated single-photon emission computed tomography for prediction of left ventricular ejection fraction outcome after coronary revascularization for ischemic cardiomyopathy. Am J Cardiol. 2002 Apr 1;89(7):817-21. doi: 10.1016/s0002-9149(02)02203-8.
PubMed 11909565
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00213746
- Acronym / sponsor ID
- 2003/011/HP
- Conditions
- Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Ischemia, Myocardial Stunning
- Keywords
- Coronary Arteriosclerosis, Heart Failure, Congestive, Myocardial Infarction, Myocardial Revascularization, Tomography, Emission-Computed, Single-Photon, Dobutamine, Myocardial Stunning, Myocardial Hibernation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, GE Healthcare, Fédération Française de Cardiologie, Société Française de Cardiologie, Société Française de Médecine Nucléaire
- Study start
- Oct 2003
- Study completion
- Dec 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Recent acute coronary syndrome (< 21 days)
- Atrial Fibrillation or significant arrhythmias
- Implanted pacemaker
- Contra indication to dobutamine
- Non ischaemic cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Background: PubMed 11923039Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8. doi: 10.1016/s0735-1097(02)01726-6.
- Background: PubMed 10541828Everaert H, Vanhove C, Franken PR. Effects of low-dose dobutamine on left ventricular function in normal subjects as assessed by gated single-photon emission tomography myocardial perfusion studies. Eur J Nucl Med. 1999 Oct;26(10):1298-303. doi: 10.1007/s002590050586.
- Background: PubMed 10805115Everaert H, Vanhove C, Franken PR. Effect of beta-blockade on low-dose dobutamine-induced changes in left ventricular function in healthy volunteers: assessment by gated SPET myocardial perfusion scintigraphy. Eur J Nucl Med. 2000 Apr;27(4):419-24. doi: 10.1007/s002590050525.
- Background: PubMed 11909565Leoncini M, Sciagra R, Maioli M, Bellandi F, Marcucci G, Sestini S, Chiocchini S, Dabizzi RP. Usefulness of dobutamine Tc-99m sestamibi-gated single-photon emission computed tomography for prediction of left ventricular ejection fraction outcome after coronary revascularization for ischemic cardiomyopathy. Am J Cardiol. 2002 Apr 1;89(7):817-21. doi: 10.1016/s0002-9149(02)02203-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Manrique, MD study chair
University Hospital, Rouen
Pierre-Yves Marie, MD study director
Central Hospital, Nancy, France
Philippe Franken, MD study director
Free University of Brussels
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis and Heart Failure, Congestive, run by University Hospital, Rouen at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213746, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.