Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Yonsei University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: December 17, 2012
Last updated: February 17, 2014
Last verified: February 2014
The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively with similar accuracy of coronary angiography using MDCTA. Early detection and intervention of CAD may provide survival benefit in renal transplant recipients.

Condition Intervention
Kidney Transplant Recipient
Other: 64-slice Multidetector coronary CT angiography

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • prevalence of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDCTA Other: 64-slice Multidetector coronary CT angiography


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age ≥ 40 yrs
  2. renal transplant recipient at post-transplant 6 to 12 months
  3. stable graft renal function: CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation ≥45 mL/min/1.75m2
  4. patients who had no previous CAD

Exclusion Criteria:

  1. unstable graft renal function
  2. History of acute kidney injury within 3 months
  3. Allergic history to contrast agent
  4. Irregular heart beat
  5. Multiorgan transplant recipients
  6. Pregnancy
  7. Patients who do not consent to this study
  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 identifier: NCT01753505

Contact: Beom Seok Kim, MD 82-2-2228-1969

Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Beom Seok Kim, MD    82-2-2228-1969   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01753505     History of Changes
Other Study ID Numbers: 4-2012-0549 
Study First Received: December 17, 2012
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
multidetector coronary CT angiography, renal transplantation processed this record on May 23, 2016