Risk Analysis for Cardiovascular Autonomic Neuropathy

Cardiovascular Autonomic Neuropathy Clinical Trial

Official title:

The Risk Analysis for Cardiovascular Autonomic Neuropathy in General Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462616
• Other study ID #: CANRA_Dr.Tang
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: September 5, 2017
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2017
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Autonomic Neuropathy
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Other:
• not intervention
This is a cross-sectional study, no intervention was performed.

Locations

Country	Name	City	State
China	Huashan 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 (12)

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. — View 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. — View 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. — View 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. — View 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. Prin — View 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-20 — View 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. — View 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 1 — 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

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. Review. — 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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular autonomic neuropathy (CAN) measured by short-term heart rate variability (HRV)		participants will be measured for the duration of outpatient stay, an expected average of 2 weeks