Clinical trial NCT00726921: Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Infarction
Stroke
Death
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-08-01
Enrollment: 189
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 19-65 with diabetes and end stage renal disease undergoing evaluation for kidney transplantation.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Detect coronary artery disease (CAD) by invasive angiography in end-stage renal disease (ESRD) patients
timeFrame: One year
Secondary outcomes:
measure: Predictive Test
timeFrame: 3 years
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNMC Department of Internal Medicine
name: Gina G Wardyn, MD
role: STUDY_DIRECTOR
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