We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01344434
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

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

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 Design

Study Type : Observational
Actual Enrollment : 167 participants
Time Perspective: Retrospective
Official Title: Angiographic CT of Renal Transplantation Candidate - Study
Study Start Date : February 2011
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates. [ Time Frame: 2013 october ]
    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 :
  1. To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG. [ Time Frame: 2013 october ]
    Blood sample of creatinine after contrast exposure.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344434


Locations
Denmark
Skejby Sygehus
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Simon Winther, MD Department of Cardiology, Skejby Sygehus, Denmark