Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Nebraska |
---|---|
Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00726921 |
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.
Condition |
---|
Coronary Artery Disease Myocardial Infarction Stroke Death |
Study Type: | Observational |
Study Design: | 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 |
Estimated Enrollment: | 75 |
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.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Adults aged 19-65 with diabetes and end stage renal disease undergoing evaluation for kidney transplantation.
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas R Porter, MD | 402-559-7977 | trporter@unmc.edu |
Contact: Gina G Wardyn, MD | 402-690-1685 | gwardyn@unmc.edu |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Thomas R Porter, MD | UNMC Department of Cardiology |
Study Director: | Gina G Wardyn, MD | UNMC Department of Internal Medicine |
Responsible Party: | UNMC Department of Cardiology ( Thomas Porter, MD ) |
Study ID Numbers: | 256-08-FB |
Study First Received: | July 29, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00726921 |
Health Authority: | United States: Institutional Review Board |
Arterial Occlusive Diseases Renal Insufficiency Death Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Kidney Failure, Chronic Arteriosclerosis |
Ischemia Coronary Disease Necrosis Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Infarction Myocardial Infarction Coronary Artery Disease Kidney Failure |
Pathologic Processes Cardiovascular Diseases |