NCT01344434

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

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

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 10, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

April 8, 2011

Last Update Submit

April 9, 2014

Conditions

Renal Transplant Candidate for Right KidneyRenal Transplant Candidate for Left Kidney

Outcome Measures

Primary Outcomes (1)

  • 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).

    2013 october

Secondary Outcomes (1)

  • To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.

    2013 october

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease (CKD) who are renal transplantation candidates. Aged \> 18

You may qualify if:

  • Endstage renal disease
  • Preparing for renal transplantation
  • Indication for CAG

You may not qualify if:

  • Known allergy to iodinated contrast
  • Women who are pregnant or nursing
  • Severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skejby Sygehus

Aarhus, 8200, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 39344509DERIVED

  • Winther 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.

    PMID: 28917674DERIVED

  • Jorgensen 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.

    PMID: 28874132DERIVED

  • Winther 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.

    PMID: 26555948DERIVED

  • Winther 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.

    PMID: 25869350DERIVED

Study Officials

  • Simon Winther, MD

    Department of Cardiology, Skejby Sygehus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 29, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 10, 2014

Record last verified: 2014-02

Locations

DK(1)