NCT03589664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

June 20, 2018

Last Update Submit

October 12, 2020

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

  • CT imaging data

    High quality CT images

    At enrollment

Study Arms (2)

Non-Sternotomy Group

Subjects who have no prior sternotomy

Sternotomy Group

Subjects who previously underwent a sternotomy procedure.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TongRen Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Zhaohui Qiu

    Tongren Hospital,Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 18, 2018

Study Start

July 20, 2018

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

CN(1)