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Sponsored by: |
Rikshospitalet HF |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00403299 |
Heart transplanted patients often develop coronary artery disease and therefore have their coronary arteries examined with coronary angiography once a year.The purpose of the study is to validate computer tomography of the coronary arteries against coronary angiography and intravascular ultrasound in heart transplanted patients. Additionally the association between different inflammatory markers and the development of CAD specific to heart transplanted patients will be studied.
Condition | Intervention |
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Coronary Artery Disease |
Procedure: MDCT of the coronary arteries. |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients |
Estimated Enrollment: | 50 |
Study Start Date: | March 2006 |
Estimated 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Günther, MD | +47 23 07 00 00 | anne.gunther@rikshospitalet.no |
Norway | |
Rikshospitalet-Radiumhospitalet HF | Recruiting |
Oslo, Norway, 0027 | |
Contact: Anne Günther, MD +47 23 07 00 00 anne.gunther@rikshospitalet.no |
Principal Investigator: | Anne Günther, MD | Rikshospitalet HF |
Study ID Numbers: | S-05203 |
Study First Received: | November 22, 2006 |
Last Updated: | November 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00403299 |
Health Authority: | Norway: The data Inspectorate.; Norway: Directorate for Health and Social Affairs |
Coronary artery disease Cardiac transplantation Coronary artery disease in heart transplanted patients |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |