Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/1/2017 |
| Start Date: | August 18, 2011 |
| End Date: | January 2017 |
Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant
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.
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.
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.
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.
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.
We found this trial at
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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