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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01527344
Other study ID # 11-003775
Secondary ID
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


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
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