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Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523194
Recruitment Status : Not yet recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Tsuchiura Kyodo General Hospital
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date August 14, 2020
First Posted Date August 21, 2020
Last Update Posted Date August 21, 2020
Estimated Study Start Date September 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2020)
Major Adverse Cardiac Events (MACE) [ Time Frame: 1 Year ]
MACE
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Official Title Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Brief Summary The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), and computed tomography angiograms (CTA) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
Detailed Description The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), and computed tomography angiograms (CTA) for future studies. About one thousand patients who underwent the above three imaging tests at Tsuchiura Kyodo General Hospital (TKGH) in Japan, will be included. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.
Condition Atherosclerosis
Intervention Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)
Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.
Study Groups/Cohorts
  • Acute Coronary Syndrome
    Patients diagnosed with acute coronary syndrome.
    Intervention: Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)
  • Stable Angina
    Patients diagnosed with stable angina.
    Intervention: Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 20, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Had CTA prior to cardiac catheterization and then OCT during catheterization

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Iris McNulty, RN 617 726 0423 imcnulty@mgh.harvard.edu
Listed Location Countries Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04523194
Other Study ID Numbers 2020P002458
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to share IPD for this observational study.
Responsible Party Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Tsuchiura Kyodo General Hospital
Investigators
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2020