Skip to content

Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Cardiovascular Autonomic Neuropathy Without a Gold Standard

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02459522
Enrollment
88
Registered
2015-06-02
Start date
2011-01-31
Completion date
2016-06-30
Last updated
2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Performance of Cardiovascular Autonomic Neuropathy

Keywords

Bayesian estimation, short-term heart rate variability, cardiovascular autonomic neuropathy, diagnostic performance

Brief summary

This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.

Detailed description

The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported about normal reference values for CAN using this test in the Chinese population. This study aimed to evaluate the reference values for the short-term HRV in a large cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset. Firstly, the reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 88 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

Interventions

This is a cross-sectional study for estimation of diagnostic performance.

Sponsors

Huashan Hospital
CollaboratorOTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Survey participants with undiagnosed CAN, aged 30-80 years, were included in this study.

Exclusion criteria

* Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function 11. Briefly, the

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular autonomic function evaluate by short-term heart rate variability testparticipants will be measured for the duration of outpatient stay, an expected average of two daysBoth short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
Cardiovascular autonomic function evaluate by Ewing's testparticipants will be measured for the duration of outpatient stay, an expected average of two daysBoth short-term heart rate variability and Ewing's test measure cardiovascular autonomic function

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026