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MDCT of the Coronary Arteries in Heart Transplanted Patients

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
MDCT of the coronary arteries.
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Cardiac transplantation, Coronary artery disease in heart transplanted patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rikshospitalet-Radiumhospitalet HF

Outcomes

Primary Outcome Measures

Coronary artery disease found on computer tomography examination at the date of examination.

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2006
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00403299
Brief Title
MDCT of the Coronary Arteries in Heart Transplanted Patients
Official Title
Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Cardiac transplantation, Coronary artery disease in heart transplanted patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
MDCT of the coronary arteries.
Primary Outcome Measure Information:
Title
Coronary artery disease found on computer tomography examination at the date of examination.
Secondary Outcome Measure Information:
Title
Coronary artery disease found on coronary angiography at the date of examination.
Title
Coronary artery disease found on intravascular ultrasound examination at the date of examination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Günther, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet-Radiumhospitalet HF
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

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MDCT of the Coronary Arteries in Heart Transplanted Patients

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