AtherosclerosisNCT04523194
Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
An observational study of Atherosclerosis, run by Massachusetts General Hospital at 2 sites in 2 countries.
Trial summary
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Nov 2020to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.
Who may be able to join
- Had CTA prior to cardiac catheterization and then OCT during catheterization
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
Read the detailed description
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. About one thousand patients who underwent coronary angiography with OCT and had a CTA prior to catheterization at Tsuchiura Kyodo General Hospital (TKGH) in Japan, will be included. A subset of these patients also had CMR. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
- Conditions
- Atherosclerosis
- Being tested
- Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)Other
Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome | Patients diagnosed with acute coronary syndrome. Receives: Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA) | |
| Stable Angina | Patients diagnosed with stable angina. Receives: Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
MACE
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start9 Nov 2020
- Primary completion19 Dec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tsuchiura Kyodo General Hospital
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523194
- Sponsor's protocol ID
- 2020P002458
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2020
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD for this observational study.
Publications
Andreaggi S, Scalamera R, Kim S, Kim K, McNulty I, Lee H, Dey D, Dijkstra J, Banning AP, Kakuta T, Jang IK. Integrated Coronary CT Angiography Assessment of Plaque Vulnerability and Clinical Outcomes: The Morphology-Inflammation-Burden (MIB) Score. JACC Cardiovasc Imaging. 2026 Aug;19(8):955-966. doi: 10.1016/j.jcmg.2026.04.017. Epub 2026 Jun 16.
PubMed 42307514Scalamera R, Covani M, Andreaggi S, Kim S, Lee H, McNulty I, Benenati S, Niccoli G, Vergallo R, Porto I, Jang IK. Non-modifiable cardiovascular risk factors and coronary plaque characteristics in patients with acute coronary syndromes. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):733-742. doi: 10.1093/ehjci/jeag023.
PubMed 41589067Kinoshita D, Suzuki K, Fujimoto D, Niida T, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. High-risk plaque features and perivascular inflammation. J Cardiovasc Comput Tomogr. 2025 May-Jun;19(3):299-305. doi: 10.1016/j.jcct.2025.01.010. Epub 2025 Feb 7.
PubMed 39922771Fujimoto D, Usui E, Vergallo R, Kinoshita D, Suzuki K, Niida T, Covani M, McNulty I, Lee H, Otake H, Shite J, Ferencik M, Dey D, Kakuta T, Jang IK. Relationship Between Coronary Artery Calcium Score and Vulnerability of Culprit Plaque Assessed by OCT in Patients With Established Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Jan;18(1):e017099. doi: 10.1161/CIRCIMAGING.124.017099. Epub 2024 Dec 20.
PubMed 39704053Niida T, Usui E, Suzuki K, Kinoshita D, Yuki H, Fujimoto D, Covani M, Dey D, Lee H, McNulty I, Ferencik M, Yonetsu T, Kakuta T, Jang IK. Differences in total plaque burden between plaque rupture and plaque erosion: A combined computed tomography angiography and optical coherence tomography study. J Cardiovasc Comput Tomogr. 2024 Nov-Dec;18(6):568-574. doi: 10.1016/j.jcct.2024.09.007. Epub 2024 Sep 24.
PubMed 39322513Kinoshita D, Suzuki K, Fujimoto D, Niida T, Usui E, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. Relationship between plaque burden and plaque vulnerability: Acute coronary syndromes versus chronic coronary syndrome. J Cardiovasc Comput Tomogr. 2024 Nov-Dec;18(6):559-566. doi: 10.1016/j.jcct.2024.09.002. Epub 2024 Sep 14.
PubMed 39278792Fujimoto D, Kinoshita D, Suzuki K, Niida T, Yuki H, McNulty I, Lee H, Otake H, Shite J, Ferencik M, Dey D, Kakuta T, Jang IK. Relationship Between Calcified Plaque Burden, Vascular Inflammation, and Plaque Vulnerability in Patients With Coronary Atherosclerosis. JACC Cardiovasc Imaging. 2024 Oct;17(10):1214-1224. doi: 10.1016/j.jcmg.2024.07.013. Epub 2024 Sep 4.
PubMed 39243232Yuki H, Sundt TM, Niida T, Suzuki K, Kinoshita D, Fujimoto D, Dey D, Lee H, McNulty I, Naganuma T, Nakamura S, Usui E, Kakuta T, Jang IK. Level of Perivascular Inflammation Is Significantly Lower Around the Left Internal Mammary Artery Than Around Native Coronary Arteries. J Am Heart Assoc. 2024 Jun 18;13(12):e033224. doi: 10.1161/JAHA.123.033224. Epub 2024 Jun 15.
PubMed 38879462Suzuki K, Kinoshita D, Niida T, Yuki H, Fujimoto D, Dey D, Lee H, McNulty I, Takano M, Mizuno K, Ferencik M, Kakuta T, Jang IK. Computed Tomography Angiography Characteristics of Thin-Cap Fibroatheroma in Patients With Diabetes. J Am Heart Assoc. 2024 May 21;13(10):e033639. doi: 10.1161/JAHA.123.033639. Epub 2024 May 14.
PubMed 38742509Niida T, Kinoshita D, Suzuki K, Yuki H, Fujimoto D, Dey D, Lee H, McNulty I, Ferencik M, Yonetsu T, Kakuta T, Jang IK. Layered plaque is associated with high levels of vascular inflammation and vulnerability in patients with stable angina pectoris. J Thromb Thrombolysis. 2024 Aug;57(6):880-887. doi: 10.1007/s11239-024-02982-3. Epub 2024 Apr 22.
PubMed 38649561Kinoshita D, Suzuki K, Yuki H, Niida T, Fujimoto D, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. Sex-Specific Association Between Perivascular Inflammation and Plaque Vulnerability. Circ Cardiovasc Imaging. 2024 Feb;17(2):e016178. doi: 10.1161/CIRCIMAGING.123.016178. Epub 2024 Feb 20.
PubMed 38377234Suzuki K, Kinoshita D, Yuki H, Niida T, Sugiyama T, Yonetsu T, Araki M, Nakajima A, Seegers LM, Dey D, Lee H, McNulty I, Takano M, Kakuta T, Mizuno K, Jang IK. Higher Noncalcified Plaque Volume Is Associated With Increased Plaque Vulnerability and Vascular Inflammation. Circ Cardiovasc Imaging. 2024 Jan;17(1):e015769. doi: 10.1161/CIRCIMAGING.123.015769. Epub 2024 Jan 11.
PubMed 38205654Park S, Yuki H, Niida T, Suzuki K, Kinoshita D, McNulty I, Broersen A, Dijkstra J, Lee H, Kakuta T, Ye JC, Jang IK. A novel deep learning model for a computed tomography diagnosis of coronary plaque erosion. Sci Rep. 2023 Dec 27;13(1):22992. doi: 10.1038/s41598-023-50483-9.
PubMed 38151502Suzuki K, Niida T, Yuki H, Kinoshita D, Fujimoto D, Lee H, McNulty I, Takano M, Nakamura S, Kakuta T, Mizuno K, Jang IK. Coronary Plaque Characteristics and Underlying Mechanism of Acute Coronary Syndromes in Different Age Groups of Patients With Diabetes. J Am Heart Assoc. 2023 Dec 5;12(23):e031474. doi: 10.1161/JAHA.123.031474. Epub 2023 Nov 28.
PubMed 38014673Kinoshita D, Suzuki K, Usui E, Hada M, Yuki H, Niida T, Minami Y, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. High-Risk Plaques on Coronary Computed Tomography Angiography: Correlation With Optical Coherence Tomography. JACC Cardiovasc Imaging. 2024 Apr;17(4):382-391. doi: 10.1016/j.jcmg.2023.08.005. Epub 2023 Sep 13.
PubMed 37715773
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
- ClinicalTrials.gov ID
- NCT04523194
- Acronym / sponsor ID
- 2020P002458
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Tsuchiura Kyodo General Hospital
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2020 (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 purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
Detailed description
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. About one thousand patients who underwent coronary angiography with OCT and had a CTA prior to catheterization at Tsuchiura Kyodo General Hospital (TKGH) in Japan, will be included. A subset of these patients also had CMR. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome | – | Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)Patients diagnosed with acute coronary syndrome. |
| Stable Angina | – | Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)Patients diagnosed with stable angina. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.
Key inclusion criteria (1 listed)
- Had CTA prior to cardiac catheterization and then OCT during catheterization
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care. | Other | Acute Coronary Syndrome, Stable Angina |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 1 Year
MACE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 42307514Andreaggi S, Scalamera R, Kim S, Kim K, McNulty I, Lee H, Dey D, Dijkstra J, Banning AP, Kakuta T, Jang IK. Integrated Coronary CT Angiography Assessment of Plaque Vulnerability and Clinical Outcomes: The Morphology-Inflammation-Burden (MIB) Score. JACC Cardiovasc Imaging. 2026 Aug;19(8):955-966. doi: 10.1016/j.jcmg.2026.04.017. Epub 2026 Jun 16.
- Derived from this study: PubMed 41589067Scalamera R, Covani M, Andreaggi S, Kim S, Lee H, McNulty I, Benenati S, Niccoli G, Vergallo R, Porto I, Jang IK. Non-modifiable cardiovascular risk factors and coronary plaque characteristics in patients with acute coronary syndromes. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):733-742. doi: 10.1093/ehjci/jeag023.
- Derived from this study: PubMed 39922771Kinoshita D, Suzuki K, Fujimoto D, Niida T, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. High-risk plaque features and perivascular inflammation. J Cardiovasc Comput Tomogr. 2025 May-Jun;19(3):299-305. doi: 10.1016/j.jcct.2025.01.010. Epub 2025 Feb 7.
- Derived from this study: PubMed 39704053Fujimoto D, Usui E, Vergallo R, Kinoshita D, Suzuki K, Niida T, Covani M, McNulty I, Lee H, Otake H, Shite J, Ferencik M, Dey D, Kakuta T, Jang IK. Relationship Between Coronary Artery Calcium Score and Vulnerability of Culprit Plaque Assessed by OCT in Patients With Established Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Jan;18(1):e017099. doi: 10.1161/CIRCIMAGING.124.017099. Epub 2024 Dec 20.
- Derived from this study: PubMed 39322513Niida T, Usui E, Suzuki K, Kinoshita D, Yuki H, Fujimoto D, Covani M, Dey D, Lee H, McNulty I, Ferencik M, Yonetsu T, Kakuta T, Jang IK. Differences in total plaque burden between plaque rupture and plaque erosion: A combined computed tomography angiography and optical coherence tomography study. J Cardiovasc Comput Tomogr. 2024 Nov-Dec;18(6):568-574. doi: 10.1016/j.jcct.2024.09.007. Epub 2024 Sep 24.
- Derived from this study: PubMed 39278792Kinoshita D, Suzuki K, Fujimoto D, Niida T, Usui E, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. Relationship between plaque burden and plaque vulnerability: Acute coronary syndromes versus chronic coronary syndrome. J Cardiovasc Comput Tomogr. 2024 Nov-Dec;18(6):559-566. doi: 10.1016/j.jcct.2024.09.002. Epub 2024 Sep 14.
- Derived from this study: PubMed 39243232Fujimoto D, Kinoshita D, Suzuki K, Niida T, Yuki H, McNulty I, Lee H, Otake H, Shite J, Ferencik M, Dey D, Kakuta T, Jang IK. Relationship Between Calcified Plaque Burden, Vascular Inflammation, and Plaque Vulnerability in Patients With Coronary Atherosclerosis. JACC Cardiovasc Imaging. 2024 Oct;17(10):1214-1224. doi: 10.1016/j.jcmg.2024.07.013. Epub 2024 Sep 4.
- Derived from this study: PubMed 38879462Yuki H, Sundt TM, Niida T, Suzuki K, Kinoshita D, Fujimoto D, Dey D, Lee H, McNulty I, Naganuma T, Nakamura S, Usui E, Kakuta T, Jang IK. Level of Perivascular Inflammation Is Significantly Lower Around the Left Internal Mammary Artery Than Around Native Coronary Arteries. J Am Heart Assoc. 2024 Jun 18;13(12):e033224. doi: 10.1161/JAHA.123.033224. Epub 2024 Jun 15.
- Derived from this study: PubMed 38742509Suzuki K, Kinoshita D, Niida T, Yuki H, Fujimoto D, Dey D, Lee H, McNulty I, Takano M, Mizuno K, Ferencik M, Kakuta T, Jang IK. Computed Tomography Angiography Characteristics of Thin-Cap Fibroatheroma in Patients With Diabetes. J Am Heart Assoc. 2024 May 21;13(10):e033639. doi: 10.1161/JAHA.123.033639. Epub 2024 May 14.
- Derived from this study: PubMed 38649561Niida T, Kinoshita D, Suzuki K, Yuki H, Fujimoto D, Dey D, Lee H, McNulty I, Ferencik M, Yonetsu T, Kakuta T, Jang IK. Layered plaque is associated with high levels of vascular inflammation and vulnerability in patients with stable angina pectoris. J Thromb Thrombolysis. 2024 Aug;57(6):880-887. doi: 10.1007/s11239-024-02982-3. Epub 2024 Apr 22.
- Derived from this study: PubMed 38377234Kinoshita D, Suzuki K, Yuki H, Niida T, Fujimoto D, Minami Y, Dey D, Lee H, McNulty I, Ako J, Ferencik M, Kakuta T, Jang IK. Sex-Specific Association Between Perivascular Inflammation and Plaque Vulnerability. Circ Cardiovasc Imaging. 2024 Feb;17(2):e016178. doi: 10.1161/CIRCIMAGING.123.016178. Epub 2024 Feb 20.
- Derived from this study: PubMed 38205654Suzuki K, Kinoshita D, Yuki H, Niida T, Sugiyama T, Yonetsu T, Araki M, Nakajima A, Seegers LM, Dey D, Lee H, McNulty I, Takano M, Kakuta T, Mizuno K, Jang IK. Higher Noncalcified Plaque Volume Is Associated With Increased Plaque Vulnerability and Vascular Inflammation. Circ Cardiovasc Imaging. 2024 Jan;17(1):e015769. doi: 10.1161/CIRCIMAGING.123.015769. Epub 2024 Jan 11.
- Individual participant dataSharing planned: No. There is no plan to share IPD for this observational study.
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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.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Massachusetts General Hospital at 2 sites in 2 countries.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: 1 Year). 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 NCT04523194, which also lists 19 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 29 Dec 2025.