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

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ClinicalTrials.gov Identifier: NCT00726921
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas R. Porter, MD, 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.

Condition or disease
Coronary Artery Disease Myocardial Infarction Stroke Death

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.

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Study Type : Observational
Actual Enrollment : 189 participants
Observational Model: Other
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
Study Start Date : August 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. To identify which of these tests is most predictive of patient outcome [ Time Frame: 3 years ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older 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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726921


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Thomas R Porter, MD UNMC Department of Cardiology
Study Director: Gina G Wardyn, MD UNMC Department of Internal Medicine
Publications:

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Responsible Party: Thomas R. Porter, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00726921    
Other Study ID Numbers: 256-08-FB
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases