A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony

This study has been withdrawn prior to enrollment.
(investigator left the institution)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01007981
First received: November 4, 2009
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 4D echo is the best modality to measure systolic dyssynchrony index [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRT device
Patients with Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years will be studied by the new echo modality.Study doesn't involve acute device implantation.

Detailed Description:

Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.

In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients followed in cardiology clinic will be included.

Criteria

Inclusion Criteria:

  • Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.

Exclusion Criteria:

  • Acute decompensated congestive heart failure.
  • chronic permanent atrial fibrillation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01007981

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Firas H El Sabbagh, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Firas El Sabbagh, university of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01007981     History of Changes
Other Study ID Numbers: 1124400
Study First Received: November 4, 2009
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014