Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

NCT02459522 | Completed DMC

• 1 other identifier: CANHRVB_Dr.Tang
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Performance of Cardiovascular Autonomic Neuropathy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Dr.Tang's research group

This group included participants with completed both the short-term HRV test and Ewing's test.

Other: not intervention

Interventions

not intervention OTHER

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

Dr.Tang's research group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with inclusion and exclusion criteria were recruited from healthy examination centres to assess cardiovascular autonomic function using both the short-term heart rate variability and Ewing's tests.

You may qualify if:

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

You may not qualify if:

• history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
• pregnancy or lactation; and/or
• serious hepatic or renal dysfunctions.

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead
• Huashan Hospital: collaborator

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

Related Publications (4)

• 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. Epub 2014 Jan 9.

  PMID: 24633734 RESULT

• 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 2013 Dec 6. No abstract available.

  PMID: 24360155 RESULT

• 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-2014-005096.

  PMID: 25287103 RESULT

• 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(1):8. doi: 10.1186/2047-783X-19-8.

  PMID: 24521230 RESULT

Study Officials

• Zihui Tang, M.D and Ph.D

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D and Ph.D

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 2, 2015
• Study Start: January 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

CN (1)