Imaging Modalities in Detection of Coronary Artery Disease in End-Stage Renal Disease Patients
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|ClinicalTrials.gov Identifier: NCT00726921|
Recruitment Status : Unknown
Verified July 2008 by University of Nebraska.
Recruitment status was: Not yet recruiting
First Posted : August 1, 2008
Last Update Posted : August 1, 2008
|Condition or disease|
|Coronary Artery Disease Myocardial Infarction Stroke Death|
Primary: To examine the ability of dobutamine stress dobutamine stress echocardiography with real time perfusion (DSE with RTCE) and coronary computed tomographic angiography (cCTA) to detect anatomically significant coronary artery disease (CAD) as defined by quantitative coronary angiography in end-stage renal disease (ESRD) patients Secondary: To identify which of these tests is most predictive of patient outcomes.
This will be a pilot study enrolling 75 participants. This is based off obtaining 80% power and a 90% rectangular confidence region for sensitivity and specificity using one-sided confidence limits, this corresponds to two 95% univariate confidence intervals (one for sensitivity and one for specificity). With 73 patients screened in total there will be 80% power to form a 90% rectangular confidence region around 90% sensitivity and 90% specificity, excluding sensitivities less than 69% and specificities less than 73%. We believe the sensitivities and specificities of both DSE with RTCE and cCTA will be within these confidence regions.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Detection of Significant Coronary Artery Disease in Nephropathy Patients Utilizing Coronary CTA and Real Time Perfusion DSE: Comparison With Quantitative Coronary Angiography and Patient Outcome|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||August 2011|
- To examine the ability of DSE with RTCE and coronary CTA to detect anatomically significant CAD as defined by invasive angiography in end-stage renal disease (ESRD) patients [ Time Frame: One year ]
- To identify which of these tests is most predictive of patient outcome [ Time Frame: 3 years ]
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): NCT00726921
|Contact: Thomas R Porter, MDfirstname.lastname@example.org|
|Contact: Gina G Wardyn, MDemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68198|
|Contact: Gina G Wardyn, MD 402-690-1685 firstname.lastname@example.org|
|Principal Investigator:||Thomas R Porter, MD||UNMC Department of Cardiology|
|Study Director:||Gina G Wardyn, MD||UNMC Department of Internal Medicine|