Clinical trial NCT01527344: Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography
Official title: Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Allograft Vasculopathy
Keywords: OCT
IVUS
CAV
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2012-02-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Transplant Patients

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.


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

Primary outcomes:
measure: Characterize CAV in-vivo with OCT
timeFrame: 1 year
Secondary outcomes:
measure: Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH
timeFrame: 1 year
measure: Predict the presence and severity of CAV with absolute counts of EPCs.
timeFrame: 1 year
measure: Predict the presence and severity of CAV with peripheral endothelial function scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Cardiovascular Diseases, Professor of Medicine, Mayo Clinic Rochester
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References: