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CT Data Collection Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589664
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
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.

Condition or disease
Cardiac Disease

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Computed Tomography Data Collection for Anatomical Analysis of Substernal Space in Patients With Cardiovascular Diseases
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019
Groups and Cohorts
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Group/Cohort
Non-Sternotomy Group
Subjects who have no prior sternotomy
Sternotomy Group
Subjects who previously underwent a sternotomy procedure.


Outcome Measures
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Primary Outcome Measures :
  1. CT imaging data [ Time Frame: At enrollment ]
    High quality CT images


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will enroll up to 100 patients who have taken or plan to take chest CT images during routine clinical procedure. The subjects will be divided into sternotomy group and non-sternotomy group based on whether the subject had undergone sternotomy.
Criteria

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
Contacts and Locations
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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): NCT03589664


Locations
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China
TongRen Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Zhaohui Qiu Tongren Hospital,Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03589664    
Other Study ID Numbers: CT Data Collection Study
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Heart Diseases
Cardiovascular Diseases