The Massachusetts General Hospital Optical Coherence Tomography Registry

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Medtronic

Boston Scientific Corporation

Massachusetts General Hospital

Information provided by (Responsible Party):

Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01110538

First received: April 22, 2010

Last updated: November 23, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2010

Last Updated Date

November 23, 2016

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Major adverse cardiac events (MACE) [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01110538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Massachusetts General Hospital Optical Coherence Tomography Registry

Official Title ^ICMJE

The Massachusetts General Hospital Optical Coherence Tomography Registry

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:

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Subjects who have intracoronary OCT imaging performed during cardiac catheterization are eligible for this registry. Subjects may be identified prior to or after cardiac catheterization and OCT imaging.

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

2714

Estimated Completion Date

May 2019

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01110538

Other Study ID Numbers ^ICMJE

2010-P-000387

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Ik-Kyung Jang, MD, PhD

Collaborators ^ICMJE

Medtronic
Boston Scientific Corporation
Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Ik-Kyung Jang, M.D., Ph.D.

Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

November 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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