Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology

NCT ID: NCT05975567

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-06-01

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.

Conditions

Coronary Artery Disease; Aortic Valve Disease; Aortic Valve Calcification; STEMI; Cardiovascular Pathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diseased cadaveric coronary arteries from individuals with sudden cardiac death

Cadaveric coronary artery segments (5-15 mm) will be excised at necropsy (post mortem) from 10 individuals with SCD likely to have advanced coronary atherosclerosis.

Three-dimensional imaging of the collected cardiac specimens

Intervention Type: OTHER

The cadaveric coronary artery 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). The thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. The surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens.

Aspirated thrombotic specimens from patients with ST-elevated myocardial infarction

Thrombotic samples will be aspirated from 30 patients with STEMI admitted to the Hippokrateion Hospital of Thessaloniki, Greece and undergoing primary PCI and routine thrombus aspiration per standardized procedures.

Three-dimensional imaging of the collected cardiac specimens

Intervention Type: OTHER

The cadaveric coronary artery 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). The thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. The surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens.

Calcific aortic valves surgically resected from patients with calcific aortic valve disease

Calcific aortic valves will be surgically removed from 30 patients with CAVD undergoing cardiac surgery for aortic valve replacement.

Three-dimensional imaging of the collected cardiac specimens

Intervention Type: OTHER

The cadaveric coronary artery 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). The thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. The surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens.

Interventions

Three-dimensional imaging of the collected cardiac specimens

The cadaveric coronary artery 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). The thrombotic specimens aspirated from patients with ST-elevated myocardial infarction, will also be scanned using micro-CT. The surgically removed aortic valves will undergo scanning with micro-CT and LSFM. Traditional histopathological assessment will also be performed on the scanned specimens.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Andreas S Papazoglou, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios I Tagarakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiothoracic Surgery Department, Aristotle University of Thessaloniki

Central Contacts

Andreas S Papazoglou, MD, MSc

Role: CONTACT

anpapazoglou@yahoo.com

+306945317584

Dimitrios V Moysidis, MD, MSc

Role: CONTACT

dimoysidis@gmail.com

+306984383937

References

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.

Reference Type: BACKGROUND

PMID: 36478204 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33991670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33969012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33572568 (View on PubMed)

Other Identifiers

5039/69589

Identifier Type: -

Identifier Source: org_study_id