ACToR-study : Angiographic CT of Renal Transplantation Candidate - Study (ACToR)

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).

Study Overview

• Status: Completed
• Conditions: Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney

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 Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Skejby Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.	Blood sample of creatinine after contrast exposure.	2013 october

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Simon Winther, MD, Department of Cardiology, Skejby Sygehus, Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 8, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: M-20100270