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

August 17, 2011
January 31, 2013
December 2009
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01783093 on ClinicalTrials.gov Archive Site
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Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia
An Evaluation of Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Patients With Sickle Cell Anemia: A Retrospective Data Review

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.

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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Patients records will be extracted from the complete medical record at OSUMC

  • Sickle Cell Anemia
  • Pulmonary Hypertension
Other: Data Collection
Collection of data from existing medical records
Sickle cell and pulmonary hypertension
Intervention: Other: Data Collection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
January 2013
January 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01783093
2009H0269
No
Namita Sood, The Ohio State University
Namita Sood
Not Provided
Principal Investigator: Namita Sood, M.D. Ohio State University
Ohio State University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP