Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT
Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT
2 other identifiers
interventional
30
1 country
1
Brief Summary
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed. Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2010
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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJuly 11, 2011
July 1, 2011
1 year
July 7, 2011
July 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular phase standard deviation.
Secondary Outcomes (4)
Left ventricular entropy
Left ventricle ejection fraction
Quality of life.
6-minutes walking test
Interventions
Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (\>85% PHR). Rest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA).
Eligibility Criteria
You may qualify if:
- Chronic heart failure with LVEF \< 35 %, QRS \> 120 ms, NYHA III/IV, optimal medical therapy for more than one month.
- Patient with stable hemodynamic for more than one month,
- More than 18-year old man or woman,
- Patient having given his free, inform and signed consent,
- Patient place setting by the social security system,
You may not qualify if:
- Psychiatric disorder
- Any contra-indication to Technetium,
- Any contra-indication to dobutamin or atropin
- Personal or family history of sudden death
- Previous severe ventricular arrhythmia
- Obstructive cardiomyopathy, severe aortic stenosis,
- Pulmonary hypertension,
- History of renal, lung, hepatic, cardiac transplantation,
- Pregnant or breast-feeding Woman,
- Patient who can not conform to the requirements of the protocol,
- Patient included in another medical study,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Centre Jean Perrincollaborator
Study Sites (1)
CHU de CLERMONT-FERRAND
Clermont-Ferrand, France
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard CITRON
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 11, 2011
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
July 11, 2011
Record last verified: 2011-07