Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

NCT01527344 | Completed DMC

• 1 other identifier: 11-003775
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Allograft Vasculopathy

Keywords

OCT; IVUS; CAV

Outcome Measures

Primary Outcomes (1)

• Characterize CAV in-vivo with OCT

  1 year

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Transplant Patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Amir Lerman, MD

  Cardiovascular Diseases, Professor of Medicine, Mayo Clinic Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

US (1)