Renal Transplant Candidate for Right KidneyACToRNCT01344434
ACToR-study : Angiographic CT of Renal Transplantation Candidate - Study
An observational study of Renal Transplant Candidate for Right Kidney and Renal Transplant Candidate for Left Kidney, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study hypothesizes that renal transplantation candidates are diagnosed with significant Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Candidate for Right Kidney, Renal Transplant Candidate for Left Kidney
- How many people
- 167 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Feb 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease (CKD) who are renal transplantation candidates. Aged > 18
Who may be able to join
- Endstage renal disease
- Preparing for renal transplantation
- Indication for CAG
Who cannot join
- Known allergy to iodinated contrast
- Women who are pregnant or nursing
- Severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angiographic CT of Renal Transplantation Candidate - Study
This study hypothesizes that renal transplantation candidates are diagnosed with significant Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities. Therefore the investigators are investigating the ability of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).
Read the detailed description
Chronic kidney disease is a known risk factor for cardiovascular disease and cardiovascular disease is the leading cause of mortality in end-stage renal disease (ESRD) patients. After renal transplantation one-half of all deaths are cardiac, usually in the first 5 years in the presence of a functional graft. Because of this renal transplantation candidates are undergoing cardiac pre-transplant risk stratification.
There is no consensus regarding which modality should be use for detection of CAD in this cardiac pre-transplant risk stratification. CAG is known as gold standard but is a invasive procedure with risk of complication.
The investigators wish to investigate the ability of detecting CAD as defined by invasive Coronary angiography (CAG) by clinical examination, blood test and non-invasive test (cCTA, MPS and acoustic CAD Patch). The investigators hypothesize that a single modality or combination of these with high sensitivity and specificity could diagnose significant CAD without the need of further invasive procedures.
This study will include 150 renal transplantations candidate.
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates.
Baseline results of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).
Measured: 2013 october
Secondary outcomes (1)
To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.
Blood sample of creatinine after contrast exposure.
Measured: 2013 october
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Candidate for Right KidneyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Winther, MD, Principal investigator, Department of Cardiology, Skejby Sygehus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344434
- Sponsor's protocol ID
- M-20100270
- Acronym
- ACToR
- Status last verified
- Feb 2014
- First submitted
- 8 Apr 2011
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahl JN, Nielsen MB, Rasmussen LD, Ivarsen P, Williams MC, Svensson MHS, Birn H, Bottcher M, Winther S. Coronary Plaque Characteristics in Patients With Chronic Kidney Failure: Impact on Cardiovascular Events and Mortality. Circ Cardiovasc Imaging. 2024 Oct;17(10):e017066. doi: 10.1161/CIRCIMAGING.124.017066. Epub 2024 Sep 30.
PubMed 39344509Winther S, Svensson M, Jorgensen HS, Rasmussen LD, Holm NR, Gormsen LC, Bouchelouche K, Botker HE, Ivarsen P, Bottcher M. Prognostic Value of Risk Factors, Calcium Score, Coronary CTA, Myocardial Perfusion Imaging, and Invasive Coronary Angiography in Kidney Transplantation Candidates. JACC Cardiovasc Imaging. 2018 Jun;11(6):842-854. doi: 10.1016/j.jcmg.2017.07.012. Epub 2017 Sep 13.
PubMed 28917674Jorgensen HS, Winther S, Bottcher M, Hauge EM, Rejnmark L, Svensson M, Ivarsen P. Bone turnover markers are associated with bone density, but not with fracture in end stage kidney disease: a cross-sectional study. BMC Nephrol. 2017 Sep 6;18(1):284. doi: 10.1186/s12882-017-0692-5.
PubMed 28874132Winther S, Bottcher M, Jorgensen HS, Bouchelouche K, Gormsen LC, Oczachowska-Kulik AE, Holm NR, Botker HE, Ivarsen PR, Svensson M. Coronary Calcium Score May Replace Cardiovascular Risk Factors as Primary Risk Stratification Tool Before Kidney Transplantation. Transplantation. 2016 Oct;100(10):2177-87. doi: 10.1097/TP.0000000000000992.
PubMed 26555948Winther S, Svensson M, Jorgensen HS, Bouchelouche K, Gormsen LC, Pedersen BB, Holm NR, Botker HE, Ivarsen P, Bottcher M. Diagnostic Performance of Coronary CT Angiography and Myocardial Perfusion Imaging in Kidney Transplantation Candidates. JACC Cardiovasc Imaging. 2015 May;8(5):553-562. doi: 10.1016/j.jcmg.2014.12.028. Epub 2015 Apr 10.
PubMed 25869350
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiographic CT of Renal Transplantation Candidate - Study
- ClinicalTrials.gov ID
- NCT01344434
- Acronym / sponsor ID
- ACToR / M-20100270
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Apr 2011 (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.
This study hypothesizes that renal transplantation candidates are diagnosed with significant Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities. Therefore the investigators are investigating the ability of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).
Detailed description
Chronic kidney disease is a known risk factor for cardiovascular disease and cardiovascular disease is the leading cause of mortality in end-stage renal disease (ESRD) patients. After renal transplantation one-half of all deaths are cardiac, usually in the first 5 years in the presence of a functional graft. Because of this renal transplantation candidates are undergoing cardiac pre-transplant risk stratification.
There is no consensus regarding which modality should be use for detection of CAD in this cardiac pre-transplant risk stratification. CAG is known as gold standard but is a invasive procedure with risk of complication.
The investigators wish to investigate the ability of detecting CAD as defined by invasive Coronary angiography (CAG) by clinical examination, blood test and non-invasive test (cCTA, MPS and acoustic CAD Patch). The investigators hypothesize that a single modality or combination of these with high sensitivity and specificity could diagnose significant CAD without the need of further invasive procedures.
This study will include 150 renal transplantations candidate.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease (CKD) who are renal transplantation candidates. Aged > 18
Key inclusion criteria (3 listed)
- Endstage renal disease
- Preparing for renal transplantation
- Indication for CAG
Key exclusion criteria (3 listed)
- Known allergy to iodinated contrast
- Women who are pregnant or nursing
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates.
Time frame: 2013 october
Baseline results of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).
1 secondary outcome
To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.
Time frame: 2013 october
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 10 Apr 2014.
- Derived from this study: PubMed 39344509Dahl JN, Nielsen MB, Rasmussen LD, Ivarsen P, Williams MC, Svensson MHS, Birn H, Bottcher M, Winther S. Coronary Plaque Characteristics in Patients With Chronic Kidney Failure: Impact on Cardiovascular Events and Mortality. Circ Cardiovasc Imaging. 2024 Oct;17(10):e017066. doi: 10.1161/CIRCIMAGING.124.017066. Epub 2024 Sep 30.
- Derived from this study: PubMed 28917674Winther S, Svensson M, Jorgensen HS, Rasmussen LD, Holm NR, Gormsen LC, Bouchelouche K, Botker HE, Ivarsen P, Bottcher M. Prognostic Value of Risk Factors, Calcium Score, Coronary CTA, Myocardial Perfusion Imaging, and Invasive Coronary Angiography in Kidney Transplantation Candidates. JACC Cardiovasc Imaging. 2018 Jun;11(6):842-854. doi: 10.1016/j.jcmg.2017.07.012. Epub 2017 Sep 13.
- Derived from this study: PubMed 28874132Jorgensen HS, Winther S, Bottcher M, Hauge EM, Rejnmark L, Svensson M, Ivarsen P. Bone turnover markers are associated with bone density, but not with fracture in end stage kidney disease: a cross-sectional study. BMC Nephrol. 2017 Sep 6;18(1):284. doi: 10.1186/s12882-017-0692-5.
- Derived from this study: PubMed 26555948Winther S, Bottcher M, Jorgensen HS, Bouchelouche K, Gormsen LC, Oczachowska-Kulik AE, Holm NR, Botker HE, Ivarsen PR, Svensson M. Coronary Calcium Score May Replace Cardiovascular Risk Factors as Primary Risk Stratification Tool Before Kidney Transplantation. Transplantation. 2016 Oct;100(10):2177-87. doi: 10.1097/TP.0000000000000992.
- Derived from this study: PubMed 25869350Winther S, Svensson M, Jorgensen HS, Bouchelouche K, Gormsen LC, Pedersen BB, Holm NR, Botker HE, Ivarsen P, Bottcher M. Diagnostic Performance of Coronary CT Angiography and Myocardial Perfusion Imaging in Kidney Transplantation Candidates. JACC Cardiovasc Imaging. 2015 May;8(5):553-562. doi: 10.1016/j.jcmg.2014.12.028. Epub 2015 Apr 10.
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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.
Simon Winther, MD principal investigator
Department of Cardiology, Skejby Sygehus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Candidate for Right Kidney and Renal Transplant Candidate for Left Kidney, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 3 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 10 Apr 2014. 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 Denmark. 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?
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates. (time frame: 2013 october). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344434, which also lists 5 linked publications.
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 10 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.