Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant (OCTCAV)
Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen in the coronary arteries of patients who have received heart transplantation. It is a major cause of morbidity and mortality in patients after heart transplant. Little progress has been made in characterizing this disease process, with more sophisticated imaging allowing for more detailed analysis of CAV, superior stratification of transplant recipients is possible and earlier interventions can be performed if necessary to prevent mortality and graft loss.
Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart transplant using this high-resolution imaging modality. It is currently the standard care for patients post-heart transplant to receive annual coronary angiograms with close follow up. Patients will be imaged using OCT at the time of their routine annual angiogram, and will be re-imaged one year later at the time of the next annual angiogram or earlier if clinically indicated. The study goal is to better characterize CAV in vivo with OCT imaging and to try to identify patterns of the disease, including intra-coronary risk assessment.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant|
- Oberservational study. There are no specific outcome measures [ Time Frame: prior to end of study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||January 2022|
|Estimated Primary Completion Date:||July 2021 (Final data collection date for primary outcome measure)|
This is a descriptive, pilot study involving the use of Galectin 3 biomarker, Optical Coherence Tomography in patients post-heart transplant with suspected Cardiac allograft vasculopathy. This study will involve imaging up to 100 patients at different points in time post heart transplant, 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. Additionally, these patients will be re-imaged with OCT during their next clinically indicated cardiac catheterization. A one-time blood draw will take place at one of the routine coronary angiogram visits. We will attempt to have imaging of all 3 major epicardial coronary arteries. In prior studies using IVUS todetect CAV, the yield was significantly higher with multi-vessels imaged.21, There will be a one-time blood draw either at baseline or during the routine reimaging. A total of 1 ml (about 5 tsps.) of blood will be collected and stored in an -80 freezer for up 1 year but will not be used for other research purposes. The tubes will be labeled with a numeric code and subject initials. Samples will be analyzed for Galectin 3 biomarker. Previously enrolled subjects will be re-consented prior to collecting the blood s ample.
Study Drugs or Devices 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.24 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.24-27 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403142
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Tamim Nazif, MD||Columbia University|