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

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01344434
First received: April 8, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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).


Condition
Renal Transplant Candidate for Right Kidney
Renal Transplant Candidate for Left Kidney

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Angiographic CT of Renal Transplantation Candidate - Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344434

Contacts
Contact: Simon Winther, MD 0045 - 89495566 simowint@rm.dk

Locations
Denmark
Skejby Sygehus Recruiting
Aarhus, Denmark, 8200
Contact: Morten Bøttcher, MD     0045 89495566        
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Simon Winther, MD Department of Cardiology, Skejby Sygehus, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01344434     History of Changes
Other Study ID Numbers: M-20100270
Study First Received: April 8, 2011
Last Updated: March 20, 2012
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on May 22, 2013