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

Aristotle University Of Thessaloniki

Status: Not yet enrolling

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

Treatments: Other: Three-dimensional imaging of the collected cardiac specimens

Study type: Observational

Funder types: Other

Identifiers

NCT05975567

5039/69589

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 3 patient groups

Diseased cadaveric coronary arteries from individuals with sudden cardiac death

Description:

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.

Treatment:

Other: Three-dimensional imaging of the collected cardiac specimens

Aspirated thrombotic specimens from patients with ST-elevated myocardial infarction

Description:

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.

Treatment:

Other: Three-dimensional imaging of the collected cardiac specimens

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

Description:

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

Treatment:

Other: Three-dimensional imaging of the collected cardiac specimens