Clinical trial NCT02462616: Risk Analysis for Cardiovascular Autonomic Neuropathy
Official title: The Risk Analysis for Cardiovascular Autonomic Neuropathy in General Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Autonomic Neuropathy
Keywords: risk analysis
general Chinese population
cardiovascular autonomic neuropathy
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
First posted: 2015-06-04
Enrollment: 2100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We recruited participants from rural and urban communities in Shanghai. Survey participants with undiagnosed CAN, aged 30-90 years, were included in this study. Our study invited a total of 3,012 subjects to a screening visit between 2011 and 2012.

Brief summary: This is a large-scale, community-based, cross-sectional study to evaluate environmental and genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.

Detailed description: A large-scale, community-based, cross-sectional study was conducted to explore the extent to which risk factors associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in demographic information, clinical biomarkers such as glucose and lipids profiles, medical and therapy history were collected. Every participants was complete DNA extracted and genotyped. Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN. In addition, clinical risk model, simply screening model and non-linear system model such as artificial neural network was created, respectively.

Eligibility criteria: Inclusion Criteria:

* Survey Chinese participants with undiagnosed CAN
* Aged 30-90 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. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  2. pregnancy or lactation
  3. serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2).
* Of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.

Primary outcomes:
measure: cardiovascular autonomic neuropathy (CAN) measured by short-term heart rate variability (HRV)
timeFrame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Zihui Tang, M.D and Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao XP, Zhu HW, Zeng F, Tang ZH. The association and interaction analysis of hypertension and uric acid on cardiovascular autonomic neuropathy. J Endocrinol Invest. 2015 Oct;38(10):1075-82. doi: 10.1007/s40618-015-0291-x. Epub 2015 Apr 23.
citation: Tang ZH, Zeng F, Zhang XZ. Human genetics of diabetic nephropathy. Ren Fail. 2015 Apr;37(3):363-71. doi: 10.3109/0886022X.2014.1000801. Epub 2015 Jan 16.
citation: Zhang L, Tang ZH, Zeng F, Li Z, Zhou L, Li Y. Clinical risk model assessment for cardiovascular autonomic dysfunction in the general Chinese population. J Endocrinol Invest. 2015 Jun;38(6):615-22. doi: 10.1007/s40618-014-0229-8. Epub 2015 Jan 3.
citation: 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.
citation: Tang ZH, Zeng F, Li Z, Zhou L. Association and predictive value analysis for resting heart rate and diabetes mellitus on cardiovascular autonomic neuropathy in general population. J Diabetes Res. 2014;2014:215473. doi: 10.1155/2014/215473. Epub 2014 Mar 18.
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. Epub 2014 Jan 9.
citation: Ge X, Pan SM, Zeng F, Tang ZH, Wang YW. A simple Chinese risk score model for screening cardiovascular autonomic neuropathy. PLoS One. 2014 Mar 12;9(3):e89623. doi: 10.1371/journal.pone.0089623. eCollection 2014.
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 2013 Dec 6. No abstract available.
citation: Tang ZH, Liu J, Zeng F, Li Z, Yu X, Zhou L. Comparison of prediction model for cardiovascular autonomic dysfunction using artificial neural network and logistic regression analysis. PLoS One. 2013 Aug 5;8(8):e70571. doi: 10.1371/journal.pone.0070571. Print 2013.
citation: Liu J, Tang ZH, Zeng F, Li Z, Zhou L. Artificial neural network models for prediction of cardiovascular autonomic dysfunction in general Chinese population. BMC Med Inform Decis Mak. 2013 Jul 31;13:80. doi: 10.1186/1472-6947-13-80.
citation: Tang ZH, Zeng F, Li Z, Zhou L. A risk score of cardiovascular autonomic dysfunction for targeted screening in the Chinese population. Int J Cardiol. 2013 Oct 12;168(5):4861-2. doi: 10.1016/j.ijcard.2013.07.062. Epub 2013 Jul 25. No abstract available.
citation: Li Z, Tang ZH, Zeng F, Zhou L. Associations between the severity of metabolic syndrome and cardiovascular autonomic function in a Chinese population. J Endocrinol Invest. 2013 Dec;36(11):993-9. doi: 10.3275/9005. Epub 2013 Jun 17.