Imaging Modalities in Detection of Coronary Artery Disease in End-Stage Renal Disease Patients
Recruitment status was Not yet recruiting
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Purpose
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: | 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 ]
| 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.
Eligibility| 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:
- Diabetes mellitus
- Patients undergoing kidney transplant evaluation.
- Currently on hemodialysis
- Adults 19-65 years of age
- 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)
- Male or female
Exclusion Criteria:
- Previous history of percutaneous coronary intervention
- Coronary artery bypass surgery
- Prior myocardial infarction or AMI (troponin greater than 1.0) within 48 hours of the test
- Atrial or ventricular arrhythmias that cannot be controlled to heart rates <65 beats per minute
- Known allergy to iodinated contrast
- Decompensated Congestive Heart failure
- Acute respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
- Pregnant (based on history/information obtained from the patient)
- Possibility that potential subject may be pregnant (based on history/information obtained from the patient)
Contacts and Locations| 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 | Not yet recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Gina G Wardyn, MD 402-690-1685 gwardyn@unmc.edu | |
| Principal Investigator: | Thomas R Porter, MD | UNMC Department of Cardiology |
| Study Director: | Gina G Wardyn, MD | UNMC Department of Internal Medicine |
More Information
Publications:
| Responsible Party: | Thomas Porter, MD, UNMC Department of Cardiology |
| ClinicalTrials.gov Identifier: | NCT00726921 History of Changes |
| Other Study ID Numbers: | 256-08-FB |
| Study First Received: | July 29, 2008 |
| Last Updated: | July 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Kidney Failure, Chronic Myocardial Infarction Stroke Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Ischemia Pathologic Processes Necrosis Renal Insufficiency, Chronic Renal Insufficiency Kidney Diseases Urologic Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013