NCT04547478

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 21, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

September 7, 2020

Last Update Submit

September 7, 2020

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Cross sectional muscle area of the 1st vertebrae level

    Cross sectional muscle area of the 1st vertebrae level by LDCT

    52 weeks

Interventions

low dose chest CT(LDCT)DIAGNOSTIC_TEST

cross sectioned muscle area of the 1st vertebrae level obtained by LDCT

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects in routine health assessments

You may qualify if:

  • 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).

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

January 21, 2019

Primary Completion

April 20, 2020

Study Completion

July 10, 2020

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)