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MDCT of the Coronary Arteries in Heart Transplanted Patients

This study is currently recruiting participants.
Verified by Rikshospitalet-Radiumhospitalet HF, November 2006

Sponsored by: Rikshospitalet-Radiumhospitalet HF
Information provided by: Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00403299
  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.

MedlinePlus related topics:   CT Scans    Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:   Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients

Further study details as provided by Rikshospitalet-Radiumhospitalet HF:

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
Estimated 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

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

Contacts
Contact: Anne Günther, MD     +47 23 07 00 00     anne.gunther@rikshospitalet.no    

Locations
Norway
Rikshospitalet-Radiumhospitalet HF     Recruiting
      Oslo, Norway, 0027
      Contact: Anne Günther, MD     +47 23 07 00 00     anne.gunther@rikshospitalet.no    

Sponsors and Collaborators
Rikshospitalet-Radiumhospitalet HF

Investigators
Principal Investigator:     Anne Günther, MD     Rikshospitalet-Radiumhospitalet HF    
  More Information


Study ID Numbers:   S-05203
First Received:   November 22, 2006
Last Updated:   November 22, 2006
ClinicalTrials.gov Identifier:   NCT00403299
Health Authority:   Norway: The data Inspectorate.;   Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet-Radiumhospitalet HF:
Coronary artery disease  
Cardiac transplantation  
Coronary artery disease in heart transplanted patients  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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