The Massachusetts General Hospital Optical Coherence Tomography Registry
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.
Coronary Artery Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Massachusetts General Hospital Optical Coherence Tomography Registry|
- Major adverse cardiac events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110538
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ik-Kyung Jang, M.D., Ph.D.||Massachusetts General Hospital|