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Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration

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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

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.

Condition or disease Intervention/treatment
Atherosclerosis Other: Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute Coronary Syndrome
Patients diagnosed with acute coronary syndrome.
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.

Stable Angina
Patients diagnosed with stable angina.
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.




Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: 1 Year ]
    MACE



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who underwent CTA prior to cardiac catheterization, and OCT during catheterization were included.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


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): NCT04523194


Contacts
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Contact: Iris McNulty, RN 617 726 0423 imcnulty@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Japan
Contact: Tsunekazu Kakuta, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Tsuchiura Kyodo General Hospital
Investigators
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Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
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Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04523194    
Other Study ID Numbers: 2020P002458
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD for this observational study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases