MDCT of the Coronary Arteries in Heart Transplanted Patients

NCT ID: NCT00403299

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-03-31

Brief Summary

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

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

MDCT of the coronary arteries.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Anne Günther, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Rikshospitalet-Radiumhospitalet HF

Oslo, , Norway

Countries

Norway

Other Identifiers

S-05203

Identifier Type: -

Identifier Source: org_study_id