The Massachusetts General Hospital Optical Coherence Tomography Registry
NCT ID: NCT01110538
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2714 participants
OBSERVATIONAL
2010-08-31
2019-04-30
Brief Summary
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Detailed Description
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The aims of the project will be:
1. identify plaque characteristics on OCT that are associated with adverse cardiac events including myocardial infarction
2. to identify characteristics of stented arteries that are associated with adverse events including restenosis and stent thrombosis
Because detailed clinical, angiographic and intravascular imaging data will be gathered from a large number of patients with clinical follow-ups, we anticipate that the registry will be a tremendous resource for additional research questions going forward.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Massachusetts General Hospital
OTHER
Ik-Kyung Jang, MD, PhD
OTHER
Responsible Party
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Ik-Kyung Jang, MD, PhD
Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging
Principal Investigators
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Ik-Kyung Jang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Cardiovascular Risk Factors and Culprit Plaque Characteristics in Women With Acute Coronary Syndromes. Am J Cardiol. 2023 Nov 15;207:13-20. doi: 10.1016/j.amjcard.2023.08.152. Epub 2023 Sep 16.
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, Kinoshita D, Suzuki K, Niida T, Nakajima A, Seegers LM, Vergallo R, Fracassi F, Russo M, Di Vito L, Bryniarski K, McNulty I, Lee H, Kakuta T, Nakamura S, Jang IK. Layered plaque and plaque volume in patients with acute coronary syndromes. J Thromb Thrombolysis. 2023 Apr;55(3):432-438. doi: 10.1007/s11239-023-02788-9. Epub 2023 Mar 4.
Seegers LM, Araki M, Nakajima A, Yonetsu T, Minami Y, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Sex Differences in Culprit Plaque Characteristics Among Different Age Groups in Patients With Acute Coronary Syndromes. Circ Cardiovasc Interv. 2022 Jun;15(6):e011612. doi: 10.1161/CIRCINTERVENTIONS.121.011612. Epub 2022 Jun 2.
Nakajima A, Araki M, Kurihara O, Minami Y, Soeda T, Yonetsu T, Higuma T, Kakuta T, McNulty I, Lee H, Malhotra R, Nakamura S, Jang IK. Predictors for Rapid Progression of Coronary Calcification: An Optical Coherence Tomography Study. J Am Heart Assoc. 2021 Feb 2;10(3):e019235. doi: 10.1161/JAHA.120.019235. Epub 2021 Jan 26.
Nakajima A, Minami Y, Araki M, Kurihara O, Soeda T, Yonetsu T, Wang Z, McNulty I, Lee H, Nakamura S, Jang IK. Optical Coherence Tomography Predictors for a Favorable Vascular Response to Statin Therapy. J Am Heart Assoc. 2021 Jan 5;10(1):e018205. doi: 10.1161/JAHA.120.018205. Epub 2020 Dec 19.
Araki M, Yonetsu T, Kurihara O, Nakajima A, Lee H, Soeda T, Minami Y, McNulty I, Uemura S, Kakuta T, Jang IK. Predictors of Rapid Plaque Progression: An Optical Coherence Tomography Study. JACC Cardiovasc Imaging. 2021 Aug;14(8):1628-1638. doi: 10.1016/j.jcmg.2020.08.014. Epub 2020 Sep 30.
Araki M, Soeda T, Kim HO, Thondapu V, Russo M, Kurihara O, Shinohara H, Minami Y, Higuma T, Lee H, Yonetsu T, Kakuta T, Jang IK. Spatial Distribution of Vulnerable Plaques: Comprehensive In Vivo Coronary Plaque Mapping. JACC Cardiovasc Imaging. 2020 Sep;13(9):1989-1999. doi: 10.1016/j.jcmg.2020.01.013. Epub 2020 Mar 16.
Sugiyama T, Yamamoto E, Bryniarski K, Xing L, Fracassi F, Lee H, Jang IK. Coronary Plaque Characteristics in Patients With Diabetes Mellitus Who Presented With Acute Coronary Syndromes. J Am Heart Assoc. 2018 Jul 13;7(14):e009245. doi: 10.1161/JAHA.118.009245.
Minami Y, Wang Z, Aguirre AD, Ong DS, Kim CJ, Uemura S, Soeda T, Lee H, Fujimoto J, Jang IK. Clinical Predictors for Lack of Favorable Vascular Response to Statin Therapy in Patients With Coronary Artery Disease: A Serial Optical Coherence Tomography Study. J Am Heart Assoc. 2017 Nov 1;6(11):e006241. doi: 10.1161/JAHA.117.006241.
Yamamoto E, Siasos G, Zaromytidou M, Coskun AU, Xing L, Bryniarski K, Zanchin T, Sugiyama T, Lee H, Stone PH, Jang IK. Low Endothelial Shear Stress Predicts Evolution to High-Risk Coronary Plaque Phenotype in the Future: A Serial Optical Coherence Tomography and Computational Fluid Dynamics Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e005455. doi: 10.1161/CIRCINTERVENTIONS.117.005455.
Xing L, Higuma T, Wang Z, Aguirre AD, Mizuno K, Takano M, Dauerman HL, Park SJ, Jang Y, Kim CJ, Kim SJ, Choi SY, Itoh T, Uemura S, Lowe H, Walters DL, Barlis P, Lee S, Lerman A, Toma C, Tan JWC, Yamamoto E, Bryniarski K, Dai J, Zanchin T, Zhang S, Yu B, Lee H, Fujimoto J, Fuster V, Jang IK. Clinical Significance of Lipid-Rich Plaque Detected by Optical Coherence Tomography: A 4-Year Follow-Up Study. J Am Coll Cardiol. 2017 May 23;69(20):2502-2513. doi: 10.1016/j.jacc.2017.03.556.
Ong DS, Lee JS, Soeda T, Higuma T, Minami Y, Wang Z, Lee H, Yokoyama H, Yokota T, Okumura K, Jang IK. Coronary Calcification and Plaque Vulnerability: An Optical Coherence Tomographic Study. Circ Cardiovasc Imaging. 2016 Jan;9(1):e003929. doi: 10.1161/CIRCIMAGING.115.003929.
Vergallo R, Papafaklis MI, Yonetsu T, Bourantas CV, Andreou I, Wang Z, Fujimoto JG, McNulty I, Lee H, Biasucci LM, Crea F, Feldman CL, Michalis LK, Stone PH, Jang IK. Endothelial shear stress and coronary plaque characteristics in humans: combined frequency-domain optical coherence tomography and computational fluid dynamics study. Circ Cardiovasc Imaging. 2014 Nov;7(6):905-11. doi: 10.1161/CIRCIMAGING.114.001932. Epub 2014 Sep 4.
Vergallo R, Joye R, Barlis P, Jia H, Tian J, Soeda T, Minami Y, Hu S, Dauerman HL, Toma C, Chan J, Lee H, Biasucci LM, Crea F, Jang IK. Bivalirudin versus unfractionated heparin for residual thrombus burden: a frequency-domain optical coherence tomography study. Catheter Cardiovasc Interv. 2015 Mar;85(4):575-82. doi: 10.1002/ccd.25631. Epub 2014 Aug 22.
Jia H, Abtahian F, Aguirre AD, Lee S, Chia S, Lowe H, Kato K, Yonetsu T, Vergallo R, Hu S, Tian J, Lee H, Park SJ, Jang YS, Raffel OC, Mizuno K, Uemura S, Itoh T, Kakuta T, Choi SY, Dauerman HL, Prasad A, Toma C, McNulty I, Zhang S, Yu B, Fuster V, Narula J, Virmani R, Jang IK. In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography. J Am Coll Cardiol. 2013 Nov 5;62(19):1748-58. doi: 10.1016/j.jacc.2013.05.071. Epub 2013 Jun 27.
Kato K, Yonetsu T, Jia H, Abtahian F, Vergallo R, Hu S, Tian J, Kim SJ, Lee H, McNulty I, Lee S, Uemura S, Jang Y, Park SJ, Mizuno K, Yu B, Jang IK. Nonculprit coronary plaque characteristics of chronic kidney disease. Circ Cardiovasc Imaging. 2013 May 1;6(3):448-56. doi: 10.1161/CIRCIMAGING.112.000165. Epub 2013 Mar 27.
Other Identifiers
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2010-P-000387
Identifier Type: -
Identifier Source: org_study_id