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

Left Ventricular Dyssynchrony Clinical Trial

Official title:

Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01390532
• Other study ID #: CHU-0096
• Secondary ID: 2010-A00265-34
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2011
• Last updated: July 8, 2011
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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,

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Left Ventricular Dyssynchrony

Intervention

Device:
• 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).

Locations

Country	Name	City	State
France	CHU de CLERMONT-FERRAND	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular phase standard deviation.			Yes
Secondary	Left ventricular entropy			Yes
Secondary	Left ventricle ejection fraction			Yes
Secondary	Quality of life.			Yes
Secondary	6-minutes walking test			Yes