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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753505
First Posted: December 20, 2012
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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. ]

Secondary Outcome Measures:
  • severity of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT01753505


Contacts
Contact: Beom Seok Kim, MD 82-2-2228-1969 docbsk@yuhs.ac

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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01753505     History of Changes
Other Study ID Numbers: 4-2012-0549
First Submitted: December 17, 2012
First Posted: December 20, 2012
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
multidetector coronary CT angiography, renal transplantation