Imaging Modalities in Detection of Coronary Artery Disease in End-Stage Renal Disease Patients
Recruitment status was Not yet recruiting
This study investigates hypothesizes that the combination of dobutamine stress echocardiography with dobutamine stress echocardiography with real time perfusion myocardial contrast echocardiography and coronary computed tomography is a better modality for detecting coronary artery disease in end-stage renal disease patients than coronary angiography, and in predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE and coronary CT at kidney transplant centers throughout the nation, leading to improved anatomical and functional detection of CAD without the need for further invasive procedures.
Coronary Artery Disease
|Study Design:||Time Perspective: Prospective|
|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|
- 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 ] [ Designated as safety issue: Yes ]
- To identify which of these tests is most predictive of patient outcome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|