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OpenTrials
Completed

NCT Number: NCT00726921

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes mellitus
  • Patients undergoing kidney transplant evaluation.
  • Currently on hemodialysis
  • Adults 19-65 years of age
  • 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)
  • Male or female

Exclusion criteria

  • Previous history of percutaneous coronary intervention
  • Coronary artery bypass surgery
  • Prior myocardial infarction or AMI (troponin greater than 1.0) within 48 hours of the test
  • Atrial or ventricular arrhythmias that cannot be controlled to heart rates <65 beats per minute
  • Known allergy to iodinated contrast
  • Decompensated Congestive Heart failure
  • Acute respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia
  • Pregnant (based on history/information obtained from the patient)
  • Possibility that potential subject may be pregnant (based on history/information obtained from the patient)

Treatment and study plan

Primary outcomes

  1. Detect coronary artery disease (CAD) by invasive angiography in end-stage renal disease (ESRD) patients

    Time frame: 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 outcomes

  1. Predictive Test

    Time frame: 3 years

    To identify which of these tests is most predictive of patient outcome

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 1, 2008
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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