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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403142
First Posted: July 27, 2011
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tamim Nazif, Columbia University
  Purpose

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
Cardiac Allograft Vasculopathy

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 Tamim Nazif, Columbia University:

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

Enrollment: 60
Actual Study Start Date: August 18, 2011
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post heart transplant
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403142


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Tamim Nazif, MD Columbia University
  More Information

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
First Submitted: July 25, 2011
First Posted: July 27, 2011
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tamim Nazif, Columbia University:
heart transplant
vasculopathy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases