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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

NCT ID: NCT01753505

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2014-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Recipient

Keywords

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multidetector coronary CT angiography, renal transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MDCTA

Group Type EXPERIMENTAL

64-slice Multidetector coronary CT angiography

Intervention Type OTHER

Interventions

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64-slice Multidetector coronary CT angiography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0549

Identifier Type: -

Identifier Source: org_study_id