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

Kidney Transplant Recipient Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753505
• Other study ID #: 4-2012-0549
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: November 26, 2017
• Start date: February 1, 2013
• Est. completion date: July 28, 2014

Study information

• Verified date: November 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 28, 2014
• Est. primary completion date: July 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Recipient

Intervention

Other:
• 64-slice Multidetector coronary CT angiography

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of coronary artery disease		at post-transplant 6 to 12 months.
Secondary	severity of coronary artery disease		at post-transplant 6 to 12 months