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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

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ClinicalTrials.gov Identifier: NCT01753505
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Kidney Transplant Recipient Other: 64-slice Multidetector coronary CT angiography

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : February 1, 2013
Primary Completion Date : July 28, 2014
Study Completion Date : July 28, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MDCTA Other: 64-slice Multidetector coronary CT angiography


Outcome Measures

Primary Outcome Measures :
  1. prevalence of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months. ]

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

Eligibility Criteria

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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

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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


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
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 Posted: December 20, 2012    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

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