MDCT of the Coronary Arteries in Heart Transplanted Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients|
- Coronary artery disease found on computer tomography examination at the date of examination.
- Coronary artery disease found on coronary angiography at the date of examination.
- Coronary artery disease found on intravascular ultrasound examination at the date of examination.
|Study Start Date:||March 2006|
|Study Completion Date:||March 2007|
Heart transplanted patients (HTx) often develop coronary artery disease (CAD) which is a major cause of graft failure and death in this group of patients. Therefore, heart transplanted patients have their coronary arteries examined annually. At present this is being done with coronary angiography. Recent development of the computed tomography (CT) technology has made it possible to examine the coronary arteries with CT angiography (CTA), which is a non-invasive method. The goal of the study is to validate CTA against coronary angiography.
Coronary artery disease lesions in heart transplanted patients differ from CAD lesions in native hearts. HTx patients develop diffuse intimal thickening affecting the whole length of the vessel starting in the periphery. These lesions specific to HTx patients are not depicted on coronary angiography. The second aim of this study is to compare the accuracy of CTA depicting such lesions with the gold-standard, intravascular ultrasound.
The third aim of this study is to study the association between different inflammatory markers and the development of CAD specific to heart transplanted patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403299
|Oslo, Norway, 0027|
|Principal Investigator:||Anne Günther, MD||Oslo University Hospital|