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The Massachusetts General Hospital Optical Coherence Tomography Registry

This study is currently recruiting participants.
Verified March 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
Medtronic
LightLab Imaging
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: March 4, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 3000
Study Start Date: August 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110538

Contacts
Contact: Christina Kratlian, M.A. 617-643-9132 ckratlian@partners.org

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

No publications provided

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
Study First Received: April 22, 2010
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013