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OpenTrials
Completed

NCT Number: NCT01110538

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ik-Kyung Jang, MD, PhD

Other

Collaborators

  • Boston Scientific Corporation
  • Massachusetts General Hospital
  • Medtronic

Registry information

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2010
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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