Coronary Artery Disease3D-CARDIOPATHNCT05975567
Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
An observational study of Coronary Artery Disease and Aortic Valve Disease, run by Aristotle University Of Thessaloniki.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Disease, Aortic Valve Calcification
- What is being tested?
- Three-dimensional imaging of the collected cardiac specimens
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology: the 3D-CARDIOPATH Study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Aortic Valve Disease, Aortic Valve Calcification, STEMI, Cardiovascular Pathology
- Being tested
- Three-dimensional imaging of the collected cardiac specimens
- Keywords
- micro-CT, light sheet fluorescence microscopy, intravascular ultrasound, optical coherence tomography, 3D cardiovascular imaging, 3D cardiovascular pathology
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Disease, Aortic Valve, Calcification of, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional imaging of the collected cardiac specimensOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Three-dimensional imaging of the collected cardiac specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 2 years
Secondary outcomes (13)
Micro-CT based quantification of the density (IU) within the scanned specimens
Quantitative density-related information will be received from micro-CT scanning of the 1) atherosclerotic plaques within the cadaveric coronary artery segments; 2) aspirated thrombotic samples; and 3) resected aortic valves (the measured density will represent the calcification).
Measured: 2 years
Micro-CT based volumetric quantification (mm3) of the scanned specimens
Quantitative volumetric information can be received from micro-CT scanning of the 1) atherosclerotic plaque volume within the cadaveric coronary artery segments; 2) aspirated thrombotic volume; and 3) resected aortic valve volume.
Measured: 2 years
Correlation of the derived images with histopathological data and visualization of regions of interest
The derived scans will be co-registered with the digital images (sections) generated by the histopathological assessment. IVUS, OCT, micro-CT and LSFM images will be matched to histopathological images (with immunohistochemistry and immunofluorescence analyses also performed). This might enable the identification of regions of interest (ROI) within the artery segments (intima, lipid-rich plaques and thrombi), the thrombotic specimens (red/white thrombus, WBC, platelets, hemosiderin) and the aortic valves (valvular cusps, amyloid, collagen and elastic fibers, valve annulus, leaflet and rest anatomic components).
Measured: 2 years
Between-modality comparison of the image resolution achieved
Minimum voxel size and maximum resolution will be recorded and compared among the different imaging modalities, where applicable.
Measured: 2 years
Between-modality comparison of the time required for image acquisition
Scanning and post-scanning reconstruction time will be recorded and compared among the different imaging modalities, where applicable.
Measured: 2 years
IVUS-based quantification of areas of interest (mm2) within the scanned cadaveric arteries
Specific measurements of coronary areas of interest (Minimum lumen area, Lumen area stenosis, and Plaque area) will be derived from IVUS scanning of the cadaveric coronary artery segments.
Measured: 2 years
IVUS-based quantification of diameters of interest (mm) within the scanned cadaveric arteries
Specific measurements of diameters of interest (Minimum lumen diameter, largest reference lumen diameter and distance from the distal to proximal reference site) will be derived from IVUS scanning of the cadaveric coronary artery segments.
Measured: 2 years
IVUS-based determination of plaque characteristics within the scanned cadaveric arteries
Specific plaque characteristics will be determined (Plaque burden and Plaque type: Thick-cap fibroatheroma, Fibrotic plaque or Fibrocalcific plaque) through IVUS scanning of the cadaveric coronary artery segments.
Measured: 2 years
IVUS-based determination of thrombotic characteristics within the scanned cadaveric arteries
If any thrombi are identified within the cadaveric coronary artery segments through IVUS scanning, thrombus characteristics will be determined according to the existing classification: 1) Acute thrombus (having an acoustic in-homogenous bright 'spontaneous contrast' appearance with sharp delineation and no clear signal attenuation), 2) Subacute thrombus (having a more homogeneous acoustic appearance and thus appearing darker), and 3) Organized thrombus (being the most acoustic homogeneous type of thrombus).
Measured: 2 years
IVUS-based quantification of the thrombus score within the scanned cadaveric arteries
The thrombus score (derived from the SPECTRUM trial) will be calculated with IVUS scanning of the cadaveric coronary artery segments: 1-point adjudication for a total thrombus length >14.5 mm, 1-point for occlusive thrombus length >1.5 mm and 1-point for maximum thrombus angle 260°; this will be summarized as low (0-1 points) and high (2-3 points) thrombus burden.
Measured: 2 years
OCT-based quantification of the assessed pathologies within the scanned cadaveric arteries
Specific measurements will be derived from OCT (attenuation coefficients for intimal tissue, lipid-rich tissue and thrombus) after scanning the cadaveric coronary artery segments.
Measured: 2 years
LSFM-based quantification of the full-width half-maximum (FWHM) within the scanned cadaveric arteries
The FWHM of the light-sheet thickness will be calculated in the Z- and -Y directions, after scanning the cadaveric coronary artery segments.
Measured: 2 years
LSFM-based quantification of the confocal parameter within the scanned cadaveric arteries
The confocal parameter will be calculated from LSFM scanning of the cadaveric coronary artery segments.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Southampton
- Responsible party
- Principal investigator, Andreas S Papazoglou, MD, Aristotle University Of Thessaloniki
- Investigators
- Georgios I Tagarakis, MD, PhD, Principal investigator, Cardiothoracic Surgery Department, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975567
- Sponsor's protocol ID
- 5039/69589
- Acronym
- 3D-CARDIOPATH
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36478204Papazoglou 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.
PubMed 33991670Karagiannidis 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.
PubMed 33969012Karagiannidis 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.
PubMed 33572568
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology: the 3D-CARDIOPATH Study
- ClinicalTrials.gov ID
- NCT05975567
- Acronym / sponsor ID
- 3D-CARDIOPATH / 5039/69589
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Southampton
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diseased cadaveric coronary arteries from individuals with sudden cardiac death | – | Other: Three-dimensional imaging of the collected cardiac specimensCadaveric coronary artery segments (5-15 mm) will be excised at necropsy (post mortem) from 10 individuals with SCD likely to have advanced coronary atherosclerosis. |
| Aspirated thrombotic specimens from patients with ST-elevated myocardial infarction | – | Other: Three-dimensional imaging of the collected cardiac specimensThrombotic 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. |
| Calcific aortic valves surgically resected from patients with calcific aortic valve disease | – | Other: Three-dimensional imaging of the collected cardiac specimensCalcific aortic valves will be surgically removed from 30 patients with CAVD undergoing cardiac surgery for aortic valve replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional imaging of the collected cardiac specimensThe 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. | Other | 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 |
Primary outcome
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).
13 secondary outcomes
Micro-CT based quantification of the density (IU) within the scanned specimens
Time frame: 2 years
Micro-CT based volumetric quantification (mm3) of the scanned specimens
Time frame: 2 years
Correlation of the derived images with histopathological data and visualization of regions of interest
Time frame: 2 years
Between-modality comparison of the image resolution achieved
Time frame: 2 years
Between-modality comparison of the time required for image acquisition
Time frame: 2 years
IVUS-based quantification of areas of interest (mm2) within the scanned cadaveric arteries
Time frame: 2 years
IVUS-based quantification of diameters of interest (mm) within the scanned cadaveric arteries
Time frame: 2 years
IVUS-based determination of plaque characteristics within the scanned cadaveric arteries
Time frame: 2 years
IVUS-based determination of thrombotic characteristics within the scanned cadaveric arteries
Time frame: 2 years
IVUS-based quantification of the thrombus score within the scanned cadaveric arteries
Time frame: 2 years
OCT-based quantification of the assessed pathologies within the scanned cadaveric arteries
Time frame: 2 years
LSFM-based quantification of the full-width half-maximum (FWHM) within the scanned cadaveric arteries
Time frame: 2 years
LSFM-based quantification of the confocal parameter within the scanned cadaveric arteries
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 36478204Papazoglou 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.
- Background: PubMed 33991670Papazoglou 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.
- Background: PubMed 33969012Karagiannidis 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.
- Background: PubMed 33572568Karagiannidis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios I Tagarakis, MD, PhD principal investigator
Cardiothoracic Surgery Department, Aristotle University of Thessaloniki
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Aortic Valve Disease, run by Aristotle University Of Thessaloniki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas S Papazoglou, MD, MSc (+306945317584, anpapazoglou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-destructive nature of the deployed imaging modalities (Number of specimens with scanning-induced alterations) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975567, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.