CT Data Collection Study

Computed Tomography Data Collection for Anatomical Analysis of Substernal Space in Patients With Cardiovascular Diseases

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Tongren Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-Sternotomy Group; Subjects who have no prior sternotomy
Sternotomy Group; Subjects who previously underwent a sternotomy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT imaging data	High quality CT images	At enrollment

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Zhaohui Qiu, Tongren Hospital,Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CT Data Collection Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No