Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

Diagnostic Performance of Cardiovascular Autonomic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459522
• Other study ID #: CANHRVB_Dr.Tang
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: September 20, 2016
• Start date: January 2011
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 exclusion criteria were as follows:

1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;

2. pregnancy or lactation; and/or

3. serious hepatic or renal dysfunctions.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diagnostic Performance of Cardiovascular Autonomic Neuropathy
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Other:
• not intervention
This is a cross-sectional study for estimation of diagnostic performance.

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine	Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-20 — View Citation

Tang ZH, Zeng F, Ye K, Yu X, Zhou L. The analysis of a reference value for baroreflex sensitivity and cardiovascular autonomic neuropathy prevalence in a Chinese population. Eur J Med Res. 2014 Feb 12;19:8. doi: 10.1186/2047-783X-19-8. — View Citation

Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub — View Citation

Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular autonomic function evaluate by short-term heart rate variability test	Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function	participants will be measured for the duration of outpatient stay, an expected average of two days	Yes
Primary	Cardiovascular autonomic function evaluate by Ewing's test	Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function	participants will be measured for the duration of outpatient stay, an expected average of two days	Yes