NCT01753505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2014

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

December 17, 2012

Last Update Submit

November 26, 2017

Conditions

Kidney Transplant Recipient

Keywords

multidetector coronary CT angiography, renal transplantation

Outcome Measures

Primary Outcomes (1)

  • prevalence of coronary artery disease

    at post-transplant 6 to 12 months.

Secondary Outcomes (1)

  • severity of coronary artery disease

    at post-transplant 6 to 12 months

Study Arms (1)

MDCTA

EXPERIMENTAL
Other: 64-slice Multidetector coronary CT angiography

Interventions

64-slice Multidetector coronary CT angiographyOTHER
MDCTA

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unstable graft renal function
  • History of acute kidney injury within 3 months
  • Allergic history to contrast agent
  • Irregular heart beat
  • Multiorgan transplant recipients
  • Pregnancy
  • Patients who do not consent to this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

February 1, 2013

Primary Completion

July 28, 2014

Study Completion

July 28, 2014

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

KR(1)