Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology: the 3D-CARDIOPATH Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 70
- Primary Endpoint
- Non-destructive nature of the deployed imaging modalities (Number of specimens with scanning-induced alterations)
Study Overview
Brief Summary
The goal of the 3D-CARDIOPATH study is to investigate the potential added value of emerging 3D imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials) in 3D. Specifically, 20 cadaveric coronary artery segments with advanced atherosclerosis will be received from 10 patients with SCD. These segments will first be scanned with intravascular imaging modalities, namely optical coherence tomography (OCT) and intravascular ultrasound (IVUS), and then with micro-computed tomography (micro-CT) and light sheet fluorescence microscopy (LSFM). Additionally, 30 thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. Finally, 30 surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens. Patient laboratory profiles, past medical histories, demographic characteristics, and therapeutic management will be recorded, where applicable.
Detailed Description
The 3D-CARDIOPATH study aims to provide 3D volumetric insights into well-characterized disease entities such as Coronary artery disease (CAD) and calcific aortic valvular disease (CAVD). Therefore, this study aims to visualize in 3D:
- cadaveric coronary artery samples collected from adults with sudden cardiac death (SCD);
- thrombotic specimens aspirated during percutaneous coronary intervention (PCI) procedures in patients with ST-elevated myocardial infarction (STEMI); and
- calcific aortic valves surgically removed from patients with CAVD undergoing cardiac surgery for valve replacement.
The utilized 3D imaging means will be:
- optical coherence tomography (OCT), intravascular ultrasound (IVUS), micro-computed tomography (micro-CT) and light sheet fluorescence microscopy (LSFM) for the assessment of the collected cadaveric coronary arteries;
- micro-CT for the assessment of the aspirated thrombotic material
- LSFM and micro-CT for the assessment of the resected aortic valves. Finally, the scanned specimens will be histopathologically assessed at the First Department of Pathology in Athens, Greece by experienced pathologist.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years.
- •Patients with sudden cardiac death for coronary artery imaging.
- •Patients with STEMI undergoing PCI and thrombus aspiration for thrombus imaging.
- •Patients with CAVD undergoing cardiac replacement of calcific aortic valve for valve imaging.
Exclusion Criteria
- •Patients dying after the execution of their cardiac surgery.
- •Patients with altered mental status; unable or unwilling to provide informed consent for specimen imaging and clinical follow-up.
Outcomes
Primary Outcomes
Non-destructive nature of the deployed imaging modalities (Number of specimens with scanning-induced alterations)
Time Frame: 2 years
The primary study outcome is to demonstrate the feasibility of ex vivo imaging of the collected cardiac specimens. Specifically, OCT, IVUS, LSFM and micro-CT will be used to scan cadaveric coronary arteries and the researchers will investigate that they can non-destructively image those specimens. Micro-CT will also be used for thrombotic material assessment and aortic valve imaging. Post-scanning histopathological assessment will be performed to confirm the non-destructiveness of the deployed imaging modalities and identify any radiation-induced or ischemic alterations within the scanned specimens.
Successful 3D visualization of the scanned specimens (generation of 3D datasets)
Time Frame: 2 years
Co-primary study aim is to successfully scan all the collected specimens and produce 3D projections of the scanned specimens (i.e., 3D datasets).
Secondary Outcomes
- IVUS-based quantification of the thrombus score within the scanned cadaveric arteries(2 years)
- Correlation of the derived images with histopathological data and visualization of regions of interest(2 years)
- Between-modality comparison of the time required for image acquisition(2 years)
- IVUS-based determination of thrombotic characteristics within the scanned cadaveric arteries(2 years)
- Micro-CT based quantification of the density (IU) within the scanned specimens(2 years)
- OCT-based quantification of the assessed pathologies within the scanned cadaveric arteries(2 years)
- LSFM-based quantification of the full-width half-maximum (FWHM) within the scanned cadaveric arteries(2 years)
- LSFM-based quantification of the confocal parameter within the scanned cadaveric arteries(2 years)
- IVUS-based quantification of areas of interest (mm2) within the scanned cadaveric arteries(2 years)
- IVUS-based quantification of diameters of interest (mm) within the scanned cadaveric arteries(2 years)
- IVUS-based determination of plaque characteristics within the scanned cadaveric arteries(2 years)
- Micro-CT based volumetric quantification (mm3) of the scanned specimens(2 years)
- Between-modality comparison of the image resolution achieved(2 years)
Investigators
Andreas S Papazoglou, MD
Principal Investigator
Aristotle University Of Thessaloniki