Left Ventricular DyssynchronyNCT01390532
Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT
A study testing 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) in people with Left Ventricular Dyssynchrony, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Ventricular Dyssynchrony
- What is being tested?
- 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Oct 2011
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
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- 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,
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de CLERMONT-FERRAND
Clermont-Ferrand
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT
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.
Read the detailed description
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).
- Conditions
- Left Ventricular Dyssynchrony
- Being tested
- 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)
- Keywords
- Left Ventricular Dyssynchrony, Gated blood-pool, D-SPECT, Pharmacological stress, NYHA III/IV, LVEF < 35 %, QRS > 120 ms, optimal medical treatment, cardiac resynchronization therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)Device
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular phase standard deviation.
Secondary outcomes (4)
Left ventricular entropy
Left ventricle ejection fraction
Quality of life.
6-minutes walking test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DyssynchronyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Jean Perrin
- Investigators
- Bernard CITRON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390532
- Sponsor's protocol ID
- CHU-0096
- Other IDs
- 2010-A00265-34
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT
- ClinicalTrials.gov ID
- NCT01390532
- Acronym / sponsor ID
- CHU-0096
- Conditions
- Left Ventricular Dyssynchrony
- Keywords
- Left Ventricular Dyssynchrony, Gated blood-pool, D-SPECT, Pharmacological stress, NYHA III/IV, LVEF < 35 %, QRS > 120 ms, optimal medical treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre Jean Perrin
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 11 Jul 2011 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)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). | Device | – |
Primary outcome
Left ventricular phase standard deviation.
4 secondary outcomes
Left ventricular entropy
Left ventricle ejection fraction
Quality of life.
6-minutes walking test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
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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.
Bernard CITRON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) in people with Left Ventricular Dyssynchrony, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular phase standard deviation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2011.