MDCT of the Coronary Arteries in Heart Transplanted Patients

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00403299
First received: November 22, 2006
Last updated: July 3, 2011
Last verified: April 2008
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: MDCT of the coronary arteries.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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.

Estimated Enrollment: 50
Study Start Date: March 2006
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403299

Locations
Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Anne Günther, MD Oslo University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403299     History of Changes
Other Study ID Numbers: S-05203
Study First Received: November 22, 2006
Last Updated: July 3, 2011
Health Authority: Norway: The data Inspectorate.
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Coronary artery disease
Cardiac transplantation
Coronary artery disease in heart transplanted patients

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014