Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT01344434
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACToR-study : Angiographic CT of Renal Transplantation Candidate - Study
Sponsor:
University of Aarhus
Organization:
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.
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:
False
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?: