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

NCT00726921 | Completed DMC

• 1 other identifier: 0256-08-FB
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Infarction; Stroke; Death

Outcome Measures

Primary Outcomes (1)

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

  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

  One year

Secondary Outcomes (1)

• Predictive Test

  3 years

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 19-65 with diabetes and end stage renal disease undergoing evaluation for kidney transplantation.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (33)

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• Kondos GT, Hoff JA, Sevrukov A, Daviglus ML, Garside DB, Devries SS, Chomka EV, Liu K. Electron-beam tomography coronary artery calcium and cardiac events: a 37-month follow-up of 5635 initially asymptomatic low- to intermediate-risk adults. Circulation. 2003 May 27;107(20):2571-6. doi: 10.1161/01.CIR.0000068341.61180.55. Epub 2003 May 12.

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• De Lima JJ, Sabbaga E, Vieira ML, de Paula FJ, Ianhez LE, Krieger EM, Ramires JA. Coronary angiography is the best predictor of events in renal transplant candidates compared with noninvasive testing. Hypertension. 2003 Sep;42(3):263-8. doi: 10.1161/01.HYP.0000087889.60760.87. Epub 2003 Aug 11.

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• Herzog CA, Marwick TH, Pheley AM, White CW, Rao VK, Dick CD. Dobutamine stress echocardiography for the detection of significant coronary artery disease in renal transplant candidates. Am J Kidney Dis. 1999 Jun;33(6):1080-90. doi: 10.1016/S0272-6386(99)70145-9.

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• Elhendy A, O'Leary EL, Xie F, McGrain AC, Anderson JR, Porter TR. Comparative accuracy of real-time myocardial contrast perfusion imaging and wall motion analysis during dobutamine stress echocardiography for the diagnosis of coronary artery disease. J Am Coll Cardiol. 2004 Dec 7;44(11):2185-91. doi: 10.1016/j.jacc.2004.08.059.

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MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Stroke; Death

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Gina G Wardyn, MD

  UNMC Department of Internal Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: August 25, 2008
• Primary Completion: December 21, 2012
• Study Completion: December 21, 2012
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)