Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00726921
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2008-07-29
Brief Title:
Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None