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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: April 6, 2015
Last verified: April 2015
History of Changes

April 22, 2010
April 6, 2015
August 2010
May 2019   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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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.
 
Active, not recruiting
2714
May 2019
May 2019   (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:
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01110538
2010-P-000387
No
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Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Ik-Kyung Jang, MD, PhD
  • Medtronic
  • Boston Scientific Corporation
  • Massachusetts General Hospital
Principal Investigator: Ik-Kyung Jang, M.D., Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
April 2015

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