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Clinical Trials/NCT01527344
NCT01527344
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country82 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Allograft Vasculopathy
Sponsor
Mayo Clinic
Enrollment
82
Locations
1
Primary Endpoint
Characterize CAV in-vivo with OCT
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amir Lerman

MD

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Characterize CAV in-vivo with OCT

Time Frame: 1 year

Secondary Outcomes

  • Predict the presence and severity of CAV with peripheral endothelial function scores(1 year)
  • Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH(1 year)
  • Predict the presence and severity of CAV with absolute counts of EPCs.(1 year)

Study Sites (1)

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