Kidney Transplant RecipientNCT01753505
Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients
A study testing 64-slice Multidetector coronary CT angiography in people with Kidney Transplant Recipient, run by Yonsei University at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- 64-slice Multidetector coronary CT angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2013to 28 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Kidney Transplant Recipient
- Being tested
- 64-slice Multidetector coronary CT angiography
- Keywords
- multidetector coronary CT angiography, renal transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64-slice Multidetector coronary CT angiographyOther
| Study group | Role | What they receive |
|---|---|---|
| MDCTA | Experimental | Not described Receives: Other: 64-slice Multidetector coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of coronary artery disease
Measured: at post-transplant 6 to 12 months.
Secondary outcomes (1)
severity of coronary artery disease
Measured: at post-transplant 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start1 Feb 2013
- Primary completion28 Jul 2014
- Study completion28 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753505
- Sponsor's protocol ID
- 4-2012-0549
- Status last verified
- Nov 2017
- First submitted
- 17 Dec 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01753505
- Acronym / sponsor ID
- 4-2012-0549
- Conditions
- Kidney Transplant Recipient
- Keywords
- multidetector coronary CT angiography, renal transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 28 Jul 2014 (actual)
- Study completion
- 28 Jul 2014 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDCTA | Experimental | Other: 64-slice Multidetector coronary CT angiography |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- unstable graft renal function
- History of acute kidney injury within 3 months
- Allergic history to contrast agent
- Irregular heart beat
- Multiorgan transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64-slice Multidetector coronary CT angiography | Other | MDCTA |
Primary outcome
prevalence of coronary artery disease
Time frame: at post-transplant 6 to 12 months.
1 secondary outcome
severity of coronary artery disease
Time frame: at post-transplant 6 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 64-slice Multidetector coronary CT angiography in people with Kidney Transplant Recipient, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of coronary artery disease (time frame: at post-transplant 6 to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.