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Completed

NCT Number: NCT00403299

MDCT of the Coronary Arteries in Heart Transplanted Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rikshospitalet-Radiumhospitalet HF

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MDCT of the coronary arteries.

Procedure

Primary outcomes

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

Secondary outcomes

  1. Coronary artery disease found on coronary angiography at the date of examination.

  2. Coronary artery disease found on intravascular ultrasound examination at the date of examination.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Multidetector Computer Tomography of the Coronary Arteries in Heart Transplanted Patients

Important dates

Study start
2006
Study completion
2007
First posted
Nov 23, 2006
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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