Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant (OCTCAV)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Tamim Nazif, Columbia University
ClinicalTrials.gov Identifier:
First received: July 25, 2011
Last updated: April 20, 2015
Last verified: April 2015

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.

Condition Phase
Cardiac Allograft Vasculopathy
Phase 4

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Oberservational study. There are no specific outcome measures [ Time Frame: prior to end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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)
Detailed 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post heart transplant

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.
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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
Sponsors and Collaborators
Columbia University
Principal Investigator: Tamim Nazif, MD Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tamim Nazif, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01403142     History of Changes
Other Study ID Numbers: AAAI1023
Study First Received: July 25, 2011
Last Updated: April 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
heart transplant

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2015