Three-dimensional Assessment of Intraventricular Dyssynchrony Using Fast Dobutamine Gated SPECT
FAST DOGS
1 other identifier
interventional
21
1 country
1
Brief Summary
The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony. Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2013
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 1, 2017
January 1, 2017
3.6 years
July 22, 2015
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
measures of dyssynchrony parameters
The primary endpoint is reproducible quantitative measures of dyssynchrony parameters between two successive acquisitions basal (entropy, bandwidth, standard deviation phase histogram).
baseline
Study Arms (1)
myocardial perfusion scintigraphy
OTHERLow-dose dobutamine gated SPECT and CZT camera for the assessment of parameters of left ventricular dyssynchrony in heart failure patients eligible for the implantation of a cardiac resynchronization device.
Interventions
Eligibility Criteria
You may qualify if:
- Patient with heart failure on optimal medical therapy and targeted for cardiac resynchronization therapy according to current recommendations;
- Age over 18 years
- Clinically stable (without hospitalization for heart failure in the last month)
- Sinus rhythm
- Social security insurance
- Signed consent form
You may not qualify if:
- Recent history (less than 21 days) of acute coronary syndrome or unstable angina;
- Recent history (less than 1 month) of acute heart failure;
- Right bundle branch block;
- Irregular heart rate;
- Double-chamber cardiac pacemaker
- Patients previously implanted with a single-chamber cardioverter-defibrillator must have at least 99 percent of unstimulated QRS.
- Countraindication to dobutamine therapy;
- Valvular heart disease, congenital heart disease, hypertrophic cardiomyopathy;
- Significant Ventricular arrhythmias;
- Hypertension (upper than 160/100 mmHg);
- Pregnant, breastfeeding or guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Médecine Nucléaire du CHU de Caen
Caen, 14000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2015
First Posted
July 29, 2015
Study Start
June 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 1, 2017
Record last verified: 2017-01