The Massachusetts General Hospital Optical Coherence Tomography Registry

Tracking Information
First Submitted Date	April 22, 2010
First Posted Date	April 26, 2010
Last Update Posted Date	November 25, 2016
Study Start Date	August 2010
Estimated Primary Completion Date	May 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 6, 2015)	Major adverse cardiac events (MACE) [ Time Frame: 1 year ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01110538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	The Massachusetts General Hospital Optical Coherence Tomography Registry
Official Title	The Massachusetts General Hospital Optical Coherence Tomography Registry
Brief Summary	Information will be collected prospectively in about 3,000 patients having Optical Coherence Tomography during cardiac catheterization. Subjects will be initially enrolled at sites outside of the United States, where Optical Coherence Tomography is approved by regulatory agencies. Subjects will be followed for up to 5 years.
Detailed Description	This project will create a prospective registry of 3,000 patients with follow-ups of up to 5 years. The aims of the project will be: identify plaque characteristics on OCT that are associated with adverse cardiac events including myocardial infarction; 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.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subjects who have intracoronary OCT imaging performed during cardiac catheterization are eligible for this registry. Subjects may be identified prior to or after cardiac catheterization and OCT imaging.
Condition	Coronary Artery Disease
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	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). pii: 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). pii: 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). pii: 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: April 6, 2015)	2714
Original Estimated Enrollment; (submitted: April 23, 2010)	3000
Estimated Study Completion Date	May 2019
Estimated Primary Completion Date	May 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Subjects who have had OCT imaging performed during cardiac catheterization and have provided written consent Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01110538
Other Study ID Numbers	2010-P-000387
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Study Sponsor	Ik-Kyung Jang, MD, PhD
Collaborators	Medtronic; Boston Scientific Corporation; Massachusetts General Hospital
Investigators	Principal Investigator: Ik-Kyung Jang, M.D., Ph.D. Massachusetts General Hospital
PRS Account	Massachusetts General Hospital
Verification Date	November 2016