MDCT of the Coronary Arteries in Heart Transplanted Patients

Coronary Artery Disease Clinical Trial

Official title:

Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403299
• Other study ID #: S-05203
• Status: Completed
• Phase: N/A
• First received: November 22, 2006
• Last updated: July 3, 2011
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: April 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The data Inspectorate.Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• MDCT of the coronary arteries.

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery disease found on computer tomography examination at the date of examination.
Secondary	Coronary artery disease found on coronary angiography at the date of examination.
Secondary	Coronary artery disease found on intravascular ultrasound examination at the date of examination.