Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

Cardiac Allograft Vasculopathy Clinical Trial

— CAV-OCT-IVUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527344
• Other study ID #: 11-003775
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: May 8, 2014
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Allograft Vasculopathy
• Vascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize CAV in-vivo with OCT		1 year	No
Secondary	Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH		1 year	No
Secondary	Predict the presence and severity of CAV with absolute counts of EPCs.		1 year	No
Secondary	Predict the presence and severity of CAV with peripheral endothelial function scores		1 year	No