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

July 8, 2011 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Left ventricular phase standard deviation.

Secondary Outcome Measures

Outcome Measure
Quality of life.
Left ventricular entropy
Left ventricle ejection fraction
6-minutes walking test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre Jean Perrin

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 8, 2011

First Posted (ESTIMATE)

July 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0096
  • 2010-A00265-34 (REGISTRY: 2010-A00265-34)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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