Clinical trial NCT05975567: Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Official title: Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology: the 3D-CARDIOPATH Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Aortic Valve Disease
Aortic Valve Calcification
STEMI
Cardiovascular Pathology
Keywords: micro-CT
light sheet fluorescence microscopy
intravascular ultrasound
optical coherence tomography
3D cardiovascular imaging
3D cardiovascular pathology
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: University of Southampton
First posted: 2023-08-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 cadaveric coronary artery segments with advanced atherosclerosis will be received from 10 patients with SCD who are likely to have advanced atherosclerosis. Additionally, 30 thrombotic specimens will be aspirated from patients presenting with STEMI. Finally, 30 aortic valves will be surgically removed from patients with CAVD undergoing cardiac surgery.

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:

1. cadaveric coronary artery samples collected from adults with sudden cardiac death (SCD);
2. thrombotic specimens aspirated during percutaneous coronary intervention (PCI) procedures in patients with ST-elevated myocardial infarction (STEMI); and
3. calcific aortic valves surgically removed from patients with CAVD undergoing cardiac surgery for valve replacement.

The utilized 3D imaging means will be:

1. 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;
2. micro-CT for the assessment of the aspirated thrombotic material
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-destructive nature of the deployed imaging modalities (Number of specimens with scanning-induced alterations)
timeFrame: 2 years
measure: Successful 3D visualization of the scanned specimens (generation of 3D datasets)
timeFrame: 2 years
Secondary outcomes:
measure: Micro-CT based quantification of the density (IU) within the scanned specimens
timeFrame: 2 years
measure: Micro-CT based volumetric quantification (mm3) of the scanned specimens
timeFrame: 2 years
measure: Correlation of the derived images with histopathological data and visualization of regions of interest
timeFrame: 2 years
measure: Between-modality comparison of the image resolution achieved
timeFrame: 2 years
measure: Between-modality comparison of the time required for image acquisition
timeFrame: 2 years
measure: IVUS-based quantification of areas of interest (mm2) within the scanned cadaveric arteries
timeFrame: 2 years
measure: IVUS-based quantification of diameters of interest (mm) within the scanned cadaveric arteries
timeFrame: 2 years
measure: IVUS-based determination of plaque characteristics within the scanned cadaveric arteries
timeFrame: 2 years
measure: IVUS-based determination of thrombotic characteristics within the scanned cadaveric arteries
timeFrame: 2 years
measure: IVUS-based quantification of the thrombus score within the scanned cadaveric arteries
timeFrame: 2 years
measure: OCT-based quantification of the assessed pathologies within the scanned cadaveric arteries
timeFrame: 2 years
measure: LSFM-based quantification of the full-width half-maximum (FWHM) within the scanned cadaveric arteries
timeFrame: 2 years
measure: LSFM-based quantification of the confocal parameter within the scanned cadaveric arteries
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Cardiothoracic Surgery Department, Aristotle University of Thessaloniki
name: Georgios I Tagarakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papazoglou AS, Karagiannidis E, Liatsos A, Bompoti A, Moysidis DV, Arvanitidis C, Tsolaki F, Tsagkaropoulos S, Theocharis S, Tagarakis G, Michaelson JS, Herrmann MD. Volumetric Tissue Imaging of Surgical Tissue Specimens Using Micro-Computed Tomography: An Emerging Digital Pathology Modality for Nondestructive, Slide-Free Microscopy-Clinical Applications of Digital Pathology in 3 Dimensions. Am J Clin Pathol. 2023 Mar 13;159(3):242-254. doi: 10.1093/ajcp/aqac143.
citation: Papazoglou AS, Karagiannidis E, Moysidis DV, Sofidis G, Bompoti A, Stalikas N, Panteris E, Arvanitidis C, Herrmann MD, Michaelson JS, Sianos G. Current clinical applications and potential perspective of micro-computed tomography in cardiovascular imaging: A systematic scoping review. Hellenic J Cardiol. 2021 Nov-Dec;62(6):399-407. doi: 10.1016/j.hjc.2021.04.006. Epub 2021 May 12.
citation: Karagiannidis E, Papazoglou AS, Sofidis G, Chatzinikolaou E, Keklikoglou K, Panteris E, Kartas A, Stalikas N, Zegkos T, Girtovitis F, Moysidis DV, Stefanopoulos L, Koupidis K, Hadjimiltiades S, Giannakoulas G, Arvanitidis C, Michaelson JS, Karvounis H, Sianos G. Micro-CT-Based Quantification of Extracted Thrombus Burden Characteristics and Association With Angiographic Outcomes in Patients With ST-Elevation Myocardial Infarction: The QUEST-STEMI Study. Front Cardiovasc Med. 2021 Apr 21;8:646064. doi: 10.3389/fcvm.2021.646064. eCollection 2021.
citation: Karagiannidis E, Papazoglou AS, Stalikas N, Deda O, Panteris E, Begou O, Sofidis G, Moysidis DV, Kartas A, Chatzinikolaou E, Keklikoglou K, Bompoti A, Gika H, Theodoridis G, Sianos G. Serum Ceramides as Prognostic Biomarkers of Large Thrombus Burden in Patients with STEMI: A Micro-Computed Tomography Study. J Pers Med. 2021 Jan 31;11(2):89. doi: 10.3390/jpm11020089.