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NCT04523194 Clinical Trial

Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration

Atherosclerosis Clinical Trial

Official title:
Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04523194
Other study ID # 2020P002458
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 9, 2020
Est. completion date December 2024

Study information
Verified date October 2023
Source Massachusetts General Hospital
Contact Iris McNulty, RN
Phone 617 726 0423
Email imcnulty@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) 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.

Description:

The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. About one thousand patients who underwent coronary angiography with OCT and had a CTA prior to catheterization at Tsuchiura Kyodo General Hospital (TKGH) in Japan, will be included. A subset of these patients also had CMR. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Had CTA prior to cardiac catheterization and then OCT during catheterization Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
Japan Tsuchiura Kyodo General Hospital Tsuchiura
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Tsuchiura Kyodo General Hospital

Countries where clinical trial is conducted

United States,  Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Events (MACE) MACE 1 Year
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