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OpenTrials
Completed

NCT Number: NCT01527344

Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 18 or older
  • patients with cardiac transplant undergoing routine CAV surveillance

Exclusion criteria

  • patients < 18 years old
  • patients with acute rejection
  • patients with active infection
  • patients with chronic renal insufficiency with a glomerular filtration rate (GFR) < 30ml/min
  • patients not able to give informed consent

Treatment and study plan

Primary outcomes

  1. Characterize CAV in-vivo with OCT

    Time frame: 1 year

Secondary outcomes

  1. Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH

    Time frame: 1 year

  2. Predict the presence and severity of CAV with absolute counts of EPCs.

    Time frame: 1 year

  3. Predict the presence and severity of CAV with peripheral endothelial function scores

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology

Acronym: CAV-OCT-IVUS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2012
Registry last updated
May 9, 2014

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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