Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients

Completed

• Conditions: Myocardial Infarction; Stroke; Coronary Artery Disease; Death

• Registration Number: NCT00726921
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Study Start: 2008-08-25
• Primary Completion: 2012-12-21
• Study Completion: 2012-12-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detect coronary artery disease (CAD) by invasive angiography in end-stage renal disease (ESRD) patients	One year	To examine the ability of 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 invasive angiography in end-stage renal disease (ESRD) patients

Secondary Outcome Measures

Name	Time	Method
Predictive Test	3 years	To identify which of these tests is most predictive of patient outcome

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States