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Coronary Artery DiseaseNCT00726921

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

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 65 years
How many people
189 participants
Where
1 siteUnited States
Study dates
25 Aug 2008to 21 Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

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

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.

Read the 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.

Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Stroke, Death

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: One year

Secondary outcomes (1)

  1. Predictive Test

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2008 (estimated)
  2. Study start25 Aug 2008
  3. Primary completion21 Dec 2012
  4. Study completion21 Dec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00726921
Sponsor's protocol ID
0256-08-FB
Status last verified
Sep 2023
First submitted
29 Jul 2008
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Ojo AO, Hanson JA, Wolfe RA, Leichtman AB, Agodoa LY, Port FK. Long-term survival in renal transplant recipients with graft function. Kidney Int. 2000 Jan;57(1):307-13. doi: 10.1046/j.1523-1755.2000.00816.x.

    PubMed 10620213

  • Reusser LM, Osborn LA, White HJ, Sexson R, Crawford MH. Increased morbidity after coronary angioplasty in patients on chronic hemodialysis. Am J Cardiol. 1994 May 15;73(13):965-7. doi: 10.1016/0002-9149(94)90142-2. No abstract available.

    PubMed 8184856

  • Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32(5 Suppl 3):S112-9. doi: 10.1053/ajkd.1998.v32.pm9820470. No abstract available.

    PubMed 9820470

  • Kasiske BL, Malik MA, Herzog CA. Risk-stratified screening for ischemic heart disease in kidney transplant candidates. Transplantation. 2005 Sep 27;80(6):815-20. doi: 10.1097/01.tp.0000173652.87417.ca.

    PubMed 16210970

  • Lentine KL, Schnitzler MA, Brennan DC, Snyder JJ, Hauptman PJ, Abbott KC, Axelrod D, Salvalaggio PR, Kasiske B. Cardiac evaluation before kidney transplantation: a practice patterns analysis in Medicare-insured dialysis patients. Clin J Am Soc Nephrol. 2008 Jul;3(4):1115-24. doi: 10.2215/CJN.05351107. Epub 2008 Apr 16.

    PubMed 18417743

  • Witczak BJ, Hartmann A, Jenssen T, Foss A, Endresen K. Routine coronary angiography in diabetic nephropathy patients before transplantation. Am J Transplant. 2006 Oct;6(10):2403-8. doi: 10.1111/j.1600-6143.2006.01491.x. Epub 2006 Sep 4.

    PubMed 16952302

  • Danovitch GM, Hariharan S, Pirsch JD, Rush D, Roth D, Ramos E, Starling RC, Cangro C, Weir MR. Management of the waiting list for cadaveric kidney transplants: report of a survey and recommendations by the Clinical Practice Guidelines Committee of the American Society of Transplantation. J Am Soc Nephrol. 2002 Feb;13(2):528-535. doi: 10.1681/ASN.V132528.

    PubMed 11805184

  • Manske CL, Thomas W, Wang Y, Wilson RF. Screening diabetic transplant candidates for coronary artery disease: identification of a low risk subgroup. Kidney Int. 1993 Sep;44(3):617-21. doi: 10.1038/ki.1993.289.

    PubMed 8231036

  • Ramanathan V, Goral S, Tanriover B, Feurer ID, Kazancioglu R, Shaffer D, Helderman JH. Screening asymptomatic diabetic patients for coronary artery disease prior to renal transplantation. Transplantation. 2005 May 27;79(10):1453-8. doi: 10.1097/01.tp.0000164147.60036.67.

    PubMed 15912119

  • Ma IW, Valantine HA, Shibata A, Waskerwitz J, Dafoe DC, Alfrey EJ, Tan JC, Millan M, Busque S, Scandling JD. Validation of a screening protocol for identifying low-risk candidates with type 1 diabetes mellitus for kidney with or without pancreas transplantation. Clin Transplant. 2006 Mar-Apr;20(2):139-46. doi: 10.1111/j.1399-0012.2005.00461.x.

    PubMed 16640517

  • Le A, Wilson R, Douek K, Pulliam L, Tolzman D, Norman D, Barry J, Bennett W. Prospective risk stratification in renal transplant candidates for cardiac death. Am J Kidney Dis. 1994 Jul;24(1):65-71. doi: 10.1016/s0272-6386(12)80161-2.

    PubMed 8023826

  • de Lemos JA, Hillis LD. Diagnosis and management of coronary artery disease in patients with end-stage renal disease on hemodialysis. J Am Soc Nephrol. 1996 Oct;7(10):2044-54. doi: 10.1681/ASN.V7102044.

    PubMed 8915964

  • Rakhit DJ, Armstrong KA, Beller E, Isbel NM, Marwick TH. Risk stratification of patients with chronic kidney disease: results of screening strategies incorporating clinical risk scoring and dobutamine stress echocardiography. Am Heart J. 2006 Aug;152(2):363-70. doi: 10.1016/j.ahj.2006.01.003.

    PubMed 16875924

  • Hedayati SS, Szczech LA. The evaluation of underlying cardiovascular disease among patients with end-stage renal disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):246-53. doi: 10.1053/j.arrt.2004.04.011.

    PubMed 15241739

  • 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.

    PubMed 12743005

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detect coronary artery disease (CAD) by invasive angiography in end-stage renal disease (ESRD) patients (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00726921, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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