MDCT of the Coronary Arteries in Heart Transplanted Patients
|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: NCT00403299|
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : July 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: MDCT of the coronary arteries.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients|
|Study Start Date :||March 2006|
|Actual Study Completion Date :||March 2007|
- 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.
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): NCT00403299
|Oslo, Norway, 0027|
|Principal Investigator:||Anne Günther, MD||Oslo University Hospital|