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A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony

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ClinicalTrials.gov Identifier: NCT01007981
Recruitment Status : Withdrawn (investigator left the institution)
First Posted : November 5, 2009
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
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 or disease
Heart Failure

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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction
Study Start Date : November 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Group/Cohort
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.



Primary Outcome Measures :
  1. 4D echo is the best modality to measure systolic dyssynchrony index [ Time Frame: Two years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007981


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

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01007981     History of Changes
Other Study ID Numbers: 1124400
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases