MDCT of the Coronary Arteries in Heart Transplanted Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: MDCT of the coronary arteries.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart transplanted patient Age 18 or above. Exclusion Criteria: Heart transplantation less than a year ago. Renal insufficiency with estimated creatinine clearance < 50 ml/min. History of contrast induced nephropathy. Known allergic reaction to CT contrast. Pregnancy Atrial Fibrillation Severe heart failure NYHA class IV. Hypotension (systolic blood pressure (BP) < 100 mmHg and/or diastolic BP<50 mmHg) or hemodynamic unstable patients. Severe pulmonary disease making the patient unable to hold his/her breath in more than 10 seconds.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MDCT of the coronary arteries.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery disease found on computer tomography examination at the date of examination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Cardiac transplantation, Coronary artery disease in heart transplanted patients