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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01344434
First received: April 8, 2011
Last updated: April 9, 2014
Last verified: February 2014

April 8, 2011
April 9, 2014
February 2011
February 2014   (final data collection date for primary outcome measure)
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates. [ Time Frame: 2013 october ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01344434 on ClinicalTrials.gov Archive Site
To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG. [ Time Frame: 2013 october ] [ Designated as safety issue: Yes ]
Blood sample of creatinine after contrast exposure.
Same as current
Not Provided
Not Provided
 
ACToR-study : Angiographic CT of Renal Transplantation Candidate - Study
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).

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Renal Transplant Candidate for Right Kidney
  • Renal Transplant Candidate for Left Kidney
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01344434
M-20100270
No
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Simon Winther, MD Department of Cardiology, Skejby Sygehus, Denmark
University of Aarhus
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP