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The Massachusetts General Hospital Optical Coherence Tomography Registry

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110538
First Posted: April 26, 2010
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic
Boston Scientific Corporation
Massachusetts General Hospital
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Massachusetts General Hospital Optical Coherence Tomography Registry

Resource links provided by NLM:


Further study details as provided by Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE) [ Time Frame: 1 year ]

Enrollment: 2714
Study Start Date: August 2010
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110538


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Ik-Kyung Jang, MD, PhD
Medtronic
Boston Scientific Corporation
Massachusetts General Hospital
Investigators
Principal Investigator: Ik-Kyung Jang, M.D., Ph.D. Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01110538     History of Changes
Other Study ID Numbers: 2010-P-000387
First Submitted: April 22, 2010
First Posted: April 26, 2010
Last Update Posted: November 25, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases