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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by University of Nebraska.
Recruitment status was:  Not yet recruiting
Information provided by:
University of Nebraska Identifier:
First received: July 29, 2008
Last updated: July 31, 2008
Last verified: July 2008
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.

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

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To identify which of these tests is most predictive of patient outcome [ Time Frame: 3 years ]

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)
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.


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 19-65 with diabetes and end stage renal disease undergoing evaluation for kidney transplantation.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00726921

Contact: Thomas R Porter, MD 402-559-7977
Contact: Gina G Wardyn, MD 402-690-1685

United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Gina G Wardyn, MD    402-690-1685   
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Thomas R Porter, MD UNMC Department of Cardiology
Study Director: Gina G Wardyn, MD UNMC Department of Internal Medicine
  More Information


Responsible Party: Thomas Porter, MD, UNMC Department of Cardiology Identifier: NCT00726921     History of Changes
Other Study ID Numbers: 256-08-FB
Study First Received: July 29, 2008
Last Updated: July 31, 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 16, 2017