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

Renal Transplant Candidate for Right Kidney Clinical Trial

— ACToR  

Official title:

Angiographic CT of Renal Transplantation Candidate - Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344434
• Other study ID #: M-20100270
• Status: Completed
• Phase: N/A
• First received: April 8, 2011
• Last updated: April 9, 2014
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Renal Transplant Candidate for Left Kidney
• Renal Transplant Candidate for Right Kidney

Locations

Country	Name	City	State
Denmark	Skejby Sygehus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.	Blood sample of creatinine after contrast exposure.	2013 october	Yes