- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547478
L1 M1 of LDCT for Low Muscle Mass Measurement
September 7, 2020 updated by: Far Eastern Memorial Hospital
Evaluation of Low Muscle Mass by Muscle Surface Index of First Lumbar Vertebrae Using Low Dose Computed Tomography
The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations.
Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3304
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
New Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
subjects in routine health assessments
Description
Inclusion Criteria:
- Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan).
Exclusion Criteria:
- nil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross sectional muscle area of the 1st vertebrae level
Time Frame: 52 weeks
|
Cross sectional muscle area of the 1st vertebrae level by LDCT
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2019
Primary Completion (Actual)
April 20, 2020
Study Completion (Actual)
July 10, 2020
Study Registration Dates
First Submitted
September 7, 2020
First Submitted That Met QC Criteria
September 7, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-107091-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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