NCT02459522

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
• Phase: —
• Study type: Observational
• Enrollment: 88 (actual)
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diagnostic Performance of Cardiovascular Autonomic Neuropathy

Interventions

Type	Name	Description
OTHER	not intervention	This is a cross-sectional study for estimation of diagnostic performance.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-06-02
• Last updated: 2016-09-22

Locations

1 site across 1 country: China