Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Neurology |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 12/12/2018 |
| Start Date: | August 2008 |
| End Date: | September 2008 |
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
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.
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.
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.
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.
Inclusion Criteria:
1. Diabetes mellitus
2. Patients undergoing kidney transplant evaluation.
3. Currently on hemodialysis
4. Adults 19-65 years of age
5. Written informed consent from a participant who is deemed medically competent by
principal investigator, secondary investigators, or participating personnel as written
in II.26 (b)
6. Male or female
Exclusion Criteria:
1. Previous history of percutaneous coronary intervention
2. Coronary artery bypass surgery
3. Prior myocardial infarction or AMI (troponin greater than 1.0) within 48 hours of the
test
4. Atrial or ventricular arrhythmias that cannot be controlled to heart rates <65 beats
per minute
5. Known allergy to iodinated contrast
6. Decompensated Congestive Heart failure
7. Acute respiratory failure as manifested by signs and symptoms of carbon dioxide
retention or hypoxemia
8. Pregnant (based on history/information obtained from the patient)
9. Possibility that potential subject may be pregnant (based on history/information
obtained from the patient)
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