Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography (CAV-OCT-IVUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Allograft Vasculopathy

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart Transplant Patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize CAV in-vivo with OCT	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Predict the presence and severity of CAV with peripheral endothelial function scores	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Amir Lerman, MD, Cardiovascular Diseases, Professor of Medicine, Mayo Clinic Rochester

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: OCT; IVUS; CAV
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 11-003775