Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:18 AM
Study NCT ID:
NCT04523194
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2020-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '1 Year', 'description': 'MACE'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '39922771', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39704053', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39322513', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39278792', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39243232', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38879462', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38742509', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38649561', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38377234', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38205654', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38151502', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38014673', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37715773', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37503629', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36866660', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36325895', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34876381', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had CTA prior to cardiac catheterization and then OCT during catheterization\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04523194', 'briefTitle': 'Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration', 'orgStudyIdInfo': {'id': '2020P002458'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Coronary Syndrome', 'description': 'Patients diagnosed with acute coronary syndrome.', 'interventionNames': ['Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)']}, {'label': 'Stable Angina', 'description': 'Patients diagnosed with stable angina.', 'interventionNames': ['Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)']}], 'interventions': [{'name': 'Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)', 'type': 'OTHER', 'description': 'Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.', 'armGroupLabels': ['Acute Coronary Syndrome', 'Stable Angina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Tsuchiura', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tsunekazu Kakuta, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Tsuchiura Kyodo General Hospital', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}], 'centralContacts': [{'name': 'Iris McNulty, RN', 'role': 'CONTACT', 'email': 'imcnulty@mgh.harvard.edu', 'phone': '617 726 0423'}], 'overallOfficials': [{'name': 'Ik-Kyung Jang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD for this observational study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tsuchiura Kyodo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Ik-Kyung Jang, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}