NCT03366987

Brief Summary

Atrial fibrillation and nonalcoholic fatty liver disease are two pathological conditions that are highly prevalent worldwide and share multiple CVD risk factors. There is rare research performed among elderly adults. The investigators are conducting a cross-sectional analysis of elderly adults (≥65 years) to investigate the association between atrial fibrillation and nonalcoholic fatty liver disease in an elderly Chinese population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

June 21, 2019

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

October 26, 2017

Last Update Submit

June 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association of nonalcoholic fatty liver disease and atrial fibrillation

    The association of nonalcoholic fatty liver disease and atrial fibrillation by chi-square test.

    the physical examination data in the year of 2014

Secondary Outcomes (2)

  • Prevalence of AF in an elderly Chinese population stratified by normal or elevated serum liver enzyme concentration

    the physical examination data in the year of 2014

  • Prevalence of AF in an elderly Chinese population stratified by NAFLD status on ultrasound combined with normal or elevated serum AST/ALT/GGT concentration

    the physical examination data in the year of 2014

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The elderly adults (≥65 years old) who had undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014

You may qualify if:

  • those who undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
  • elderly adults (≥65 years old)

You may not qualify if:

  • unknown alcohol intake or excessive alcohol intake
  • unknown BMI or BMI≤18.0kg/m2
  • incomplete basic physical data
  • missing liver ultrasonic diagnosis
  • unknown causes of chronic liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseAtrial Fibrillation

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lei Xu, Dr.

    Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2017

First Posted

December 8, 2017

Study Start

December 12, 2017

Primary Completion

January 18, 2018

Study Completion

January 30, 2018

Last Updated

June 21, 2019

Record last verified: 2018-07

Locations