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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00726921
First received: July 29, 2008
Last updated: July 31, 2008
Last verified: July 2008
  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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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.

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)
  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 ClinicalTrials.gov identifier: NCT00726921

Contacts
Contact: Thomas R Porter, MD 402-559-7977 trporter@unmc.edu
Contact: Gina G Wardyn, MD 402-690-1685 gwardyn@unmc.edu

Locations
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   
Sponsors and Collaborators
University of Nebraska
Investigators
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:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014