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Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Namita Sood, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01783093
First received: August 17, 2011
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension.

It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.


Condition Intervention
Sickle Cell Anemia
Pulmonary Hypertension
 Other: Data Collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Evaluation of Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Patients With Sickle Cell Anemia: A Retrospective Data Review

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • A retrospective review on patients who have had multiple echocardiograms to determine if patients with a normalization of TR Jet Velocity have changes in risk of death compared with those who do not have normalization of TR Jet Velocity. [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
    Any subject's who meet criteria and have multiple echocardiograms may be included.


Enrollment: 209
Study Start Date: December 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sickle cell and pulmonary hypertension Other: Data Collection
Collection of data from existing medical records

  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 records will be extracted from the complete medical record at OSUMC

Criteria

To limit bias in this study all patients that with sickle cell anemia and pulmonary hypertension with the pre-specified data required will be included.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783093

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Namita Sood
Investigators
Principal Investigator: Namita Sood, M.D. Ohio State University
  More Information

Publications:

Responsible Party: Namita Sood, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01783093     History of Changes
Other Study ID Numbers: 2009H0269
Study First Received: August 17, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hypertension
Hypertension, Pulmonary
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Hemoglobinopathies
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013