- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523194
Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
December 22, 2025 updated by: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tsuchiura, Japan
- Tsuchiura Kyodo General Hospital
-
-
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.
Description
Inclusion Criteria:
- Had CTA prior to cardiac catheterization and then OCT during catheterization
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acute Coronary Syndrome
Patients diagnosed with acute coronary syndrome.
|
Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.
|
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Stable Angina
Patients diagnosed with stable angina.
|
Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major Adverse Cardiac Events (MACE)
Time Frame: 1 Year
|
MACE
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Araki M, Sugiyama T, Nakajima A, Yonetsu T, Seegers LM, Dey D, Lee H, McNulty I, Yasui Y, Teng Y, Nagamine T, Kakuta T, Jang IK. Level of Vascular Inflammation Is Higher in Acute Coronary Syndromes Compared with Chronic Coronary Disease. Circ Cardiovasc Imaging. 2022 Nov;15(11):e014191. doi: 10.1161/CIRCIMAGING.122.014191. Epub 2022 Nov 3.
- Nakajima A, Sugiyama T, Araki M, Seegers LM, Dey D, McNulty I, Lee H, Yonetsu T, Yasui Y, Teng Y, Nagamine T, Nakamura S, Achenbach S, Kakuta T, Jang IK. Plaque Rupture, Compared With Plaque Erosion, Is Associated With a Higher Level of Pancoronary Inflammation. JACC Cardiovasc Imaging. 2022 May;15(5):828-839. doi: 10.1016/j.jcmg.2021.10.014. Epub 2021 Nov 8.
- Kinoshita 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.
- Fujimoto 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.
- Niida 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.
- Kinoshita 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.
- Fujimoto 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.
- Yuki 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.
- Suzuki 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.
- Niida 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.
- Kinoshita 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.
- Suzuki 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.
- Park 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.
- Suzuki 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.
- Kinoshita 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.
- Seegers LM, DeFaria Yeh D, Yonetsu T, Sugiyama T, Minami Y, Soeda T, Araki M, Nakajima A, Yuki H, Kinoshita D, Suzuki K, Niida T, Lee H, McNulty I, Nakamura S, Kakuta T, Fuster V, Jang IK. Sex Differences in Coronary Atherosclerotic Phenotype and Healing Pattern on Optical Coherence Tomography Imaging. Circ Cardiovasc Imaging. 2023 Aug;16(8):e015227. doi: 10.1161/CIRCIMAGING.123.015227. Epub 2023 Jul 28.
- Yuki H, Sugiyama T, Suzuki K, Kinoshita D, Niida T, Nakajima A, Araki M, Dey D, Lee H, McNulty I, Nakamura S, Kakuta T, Jang IK. Coronary Inflammation and Plaque Vulnerability: A Coronary Computed Tomography and Optical Coherence Tomography Study. Circ Cardiovasc Imaging. 2023 Mar;16(3):e014959. doi: 10.1161/CIRCIMAGING.122.014959. Epub 2023 Mar 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 9, 2020
Primary Completion (Actual)
December 19, 2025
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 14, 2020
First Submitted That Met QC Criteria
August 20, 2020
First Posted (Actual)
August 21, 2020
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P002458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD for this observational study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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