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NCT Number: NCT01344434

ACToR-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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skejby Sygehus

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Angiographic CT of Renal Transplantation Candidate - Study

Acronym: ACToR

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2011
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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