This trial is active, not recruiting.

Condition cardiac allograft vasculopathy
Phase phase 4
Sponsor Columbia University
Start date July 2011
End date July 2021
Trial size 100 participants
Trial identifier NCT01403142, AAAI1023


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Oberservational study. There are no specific outcome measures
time frame: prior to end of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Post heart transplant patients - Patients presenting for their routine annual or clinically indicated coronary angiogram post-heart transplant. The decision for coronary angiogram will be made by the treating physician from the heart-failure-transplant team (not by the physician who will do the angiogram) - Clinically suspect or evidence of CAV in previous coronary angiogram - Age > 18 - Written informed-consent obtained Exclusion Criteria: - Any complications that occur during routine biopsy of the coronary arteries during the same cath-lab visit - Baseline renal failure with Cr > 1.8 - Contraindication for anticoagulation - Any other condition that in the opinion of the investigators would alter the safety of participation, or interfere with the ability to adhere to study procedures.

Additional Information

Official title Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant
Principal investigator Tamim Nazif, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Columbia University.