Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01390532
• Collaborator: Centre Jean Perrin (Other)
• Enrollment: 30
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Dyssynchrony	Device: 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT
• Study Start Date: Aug 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2011
• Anticipated Study Completion Date: Oct 1, 2011

Outcome Measures

Primary Outcome Measures

1. Left ventricular phase standard deviation. []

Secondary Outcome Measures

1. Left ventricular entropy []

2. Left ventricle ejection fraction []

3. Quality of life. []

4. 6-minutes walking test []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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,

Exclusion Criteria:

• 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de CLERMONT-FERRAND	Clermont-Ferrand		France

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand
• Centre Jean Perrin

Investigators

• Principal Investigator: Bernard CITRON, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01390532
• Other Study ID Numbers: CHU-0096; 2010-A00265-34
• First Posted: Jul 11, 2011
• Last Update Posted: Jul 11, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Left Ventricular Dyssynchrony; Gated blood-pool; D-SPECT; Pharmacological stress; NYHA III/IV; LVEF < 35 %; QRS > 120 ms; optimal medical treatment; cardiac resynchronization therapy

Study Results

No Results Posted as of Jul 11, 2011