The Massachusetts General Hospital Optical Coherence Tomography Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01110538
• Lead Sponsor: Ik-Kyung Jang, MD, PhD

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:

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.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-08
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2714

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	1 year

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States