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

NCT05975567 | Unknown

• 1 other identifier: 5039/69589
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Non-destructive nature of the deployed imaging modalities (Number of specimens with scanning-induced alterations)

  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.

  2 years

• Successful 3D visualization of the scanned specimens (generation of 3D datasets)

  Co-primary study aim is to successfully scan all the collected specimens and produce 3D projections of the scanned specimens (i.e., 3D datasets).

  2 years

Secondary Outcomes (13)

• Micro-CT based quantification of the density (IU) within the scanned specimens

  2 years

• Micro-CT based volumetric quantification (mm3) of the scanned specimens

  2 years

• Correlation of the derived images with histopathological data and visualization of regions of interest

  2 years

• Between-modality comparison of the image resolution achieved

  2 years

• Between-modality comparison of the time required for image acquisition

  2 years

Study Arms (3)

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.

Other: Three-dimensional imaging of the collected cardiac 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.

Other: Three-dimensional imaging of the collected cardiac 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.

Other: Three-dimensional imaging of the collected cardiac specimens

Interventions

Three-dimensional imaging of the collected cardiac specimens 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; Calcific aortic valves surgically resected from patients with calcific aortic valve disease; Diseased cadaveric coronary arteries from individuals with sudden cardiac death

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• National and Kapodistrian University of Athens: collaborator
• University of Southampton: collaborator

Related Publications (4)

• 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.

  PMID: 36478204 BACKGROUND

• 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.

  PMID: 33991670 BACKGROUND

• 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.

  PMID: 33969012 BACKGROUND

• 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.

  PMID: 33572568 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Our study aims to collect: 1. 20 cadaveric coronary artery segments collected from 10 adults with sudden cardiac death (SCD); 2. 30 thrombotic specimens aspirated during percutaneous coronary intervention (PCI) procedures in patients with ST-elevated myocardial infarction (STEMI); 3. 30 calcific aortic valves surgically removed from patients with CAVD undergoing cardiac surgery for valve replacement.

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease; Aortic Valve, Calcification of; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Georgios I Tagarakis, MD, PhD

  Cardiothoracic Surgery Department, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas S Papazoglou, MD, MSc

CONTACT

+306945317584; anpapazoglou@yahoo.com

Dimitrios V Moysidis, MD, MSc

CONTACT

+306984383937; dimoysidis@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 4, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-08