The Massachusetts General Hospital Optical Coherence Tomography Registry

This study is currently recruiting participants.
Verified December 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: December 4, 2013
Last verified: December 2013

April 22, 2010
December 4, 2013
August 2010
June 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01110538 on ClinicalTrials.gov Archive Site
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The Massachusetts General Hospital Optical Coherence Tomography Registry
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
June 2018
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: James Chan 617-643-9132 jchan12@partners.org
United States
 
NCT01110538
2010-P-000387
No
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Ik-Kyung Jang, MD, PhD
  • Medtronic
  • LightLab Imaging
  • Massachusetts General Hospital
Principal Investigator: Ik-Kyung Jang, M.D., Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
December 2013

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