OCTCAVOptical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases
+ Vascular Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: August 18, 2011
Actual date on which the first participant was enrolled.This study will involve imaging up to 100 patients at different points in time post heart transplant as part of their standard of care, with various degrees of disease and with different lesion subtypes. Imaging will take place at the time of routine coronary angiogram, which is standard of care in this patient population,or when clinically indicated. In prior studies using IVUS todetect CAV, the yield was significantly higher with multi-vessels imaged. OCT is an intravascular light-based imaging modality that measures the intensity of reflected light waves and converts these echoes into a high-resolution tomographic image. It is a catheter-based invasive imaging system analogous to IVUS but uses light as opposed to ultrasound to generate in vivo images of coronary arteries. It has the highest resolution of any intravascular imaging modality, capable of obtaining detailed cross-sectional images of coronary arteries in vivo at a resolution of 10 um or near histologic. This device, which is FDA approved for intracoronary evaluation, has been used in evaluating patients with coronary artery disease, specifically for plaque composition analysis, as well as for proper stent deployment after percutaneous intervention.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Columbia University Medical Center
New York, United StatesOpen Columbia University Medical Center in Google Maps