The Massachusetts General Hospital Optical Coherence Tomography Registry

Ik-Kyung Jang, MD, PhD

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01110538

2010-P-000387

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 2,714 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have had OCT imaging performed during cardiac catheterization and have provided written consent

Exclusion criteria

• None