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The Massachusetts General Hospital Optical Coherence Tomography Registry

The Massachusetts General Hospital Optical Coherence Tomography Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01110538
Enrollment
2714
Registered
2010-04-26
Start date
2010-08-31
Completion date
2019-04-30
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Sponsors

Medtronic
CollaboratorINDUSTRY
Boston Scientific Corporation
CollaboratorINDUSTRY
Massachusetts General Hospital
CollaboratorOTHER
Ik-Kyung Jang, MD, PhD
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac events (MACE)1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026