Viewing Study NCT01344434



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Study NCT ID: NCT01344434
Status: COMPLETED
Last Update Posted: 2014-04-10
First Post: 2011-04-08

Brief Title: ACToR-study Angiographic CT of Renal Transplantation Candidate - Study
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: Angiographic CT of Renal Transplantation Candidate - Study
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACToR
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None