CT Data Collection Study

NCT ID: NCT03589664

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-12-15

Brief Summary

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The primary objective of this study is to gather chest CT images as part of routine clinical procedure from subjects with and without prior sternotomy to characterize the substernal space. Specifically, the study will provide references for physicians to better understand substernal anatomy.

Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Non-Sternotomy Group

Subjects who have no prior sternotomy

No interventions assigned to this group

Sternotomy Group

Subjects who previously underwent a sternotomy procedure.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject must be≥18 years old
* Subject must be indicated for high quality chest CT imaging as part of routine clinical procedure
* Subject must be willing to provide Informed Consent

Exclusion Criteria

* Subject has medical conditions that would limit study participation
* Subject is pregnant or have a pregnancy plan during the study
* Subject is enrolled in a concurrent study that may confound the results of this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhaohui Qiu

Role: PRINCIPAL_INVESTIGATOR

Tongren Hospital,Shanghai Jiao Tong University School of Medicine

Locations

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TongRen Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CT Data Collection Study

Identifier Type: -

Identifier Source: org_study_id

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