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.
Sponsor:
Information provided by (Responsible Party):
Tamim Nazif, Columbia University
ClinicalTrials.gov Identifier:
NCT01403142
First received: July 25, 2011
Last updated: February 5, 2015
Last verified: February 2015

July 25, 2011
February 5, 2015
July 2011
July 2021   (final data collection date for primary outcome measure)
Oberservational study. There are no specific outcome measures [ Time Frame: prior to end of study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01403142 on ClinicalTrials.gov Archive Site
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Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Post heart transplant

Cardiac Allograft Vasculopathy
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Dong L, Maehara A, Nazif TM, Pollack AT, Saito S, Rabbani LE, Apfelbaum MA, Dalton K, Moses JW, Jorde UP, Xu K, Mintz GS, Mancini DM, Weisz G. Optical coherence tomographic evaluation of transplant coronary artery vasculopathy with correlation to cellular rejection. Circ Cardiovasc Interv. 2014 Apr;7(2):199-206. doi: 10.1161/CIRCINTERVENTIONS.113.000949. Epub 2014 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
January 2022
July 2021   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01403142
AAAI1023
No
Tamim Nazif, Columbia University
Columbia University
Not Provided
Principal Investigator: Tamim Nazif, MD Columbia University
Columbia University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP