Viewing Study NCT00403299



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Study NCT ID: NCT00403299
Status: COMPLETED
Last Update Posted: 2011-07-06
First Post: 2006-11-22

Brief Title: MDCT of the Coronary Arteries in Heart Transplanted Patients
Sponsor: Oslo University Hospital
Organization: Oslo University Hospital

Study Overview

Official Title: Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients
Status: COMPLETED
Status Verified Date: 2008-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Heart transplanted patients often develop coronary artery disease and therefore have their coronary arteries examined with coronary angiography once a yearThe 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None