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

Completed

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

• Registration Number: NCT01344434
• Lead Sponsor: University of Aarhus

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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates.	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Skejby Sygehus; 🇩🇰 Aarhus, Denmark