Risk Analysis for Cardiovascular Autonomic Neuropathy

NCT ID: NCT02462616

Last Updated: 2017-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Autonomic Neuropathy

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dr.Tang's research group

Dr.Tang's research group for clinical risk analysis of human complex disease

not intervention

Intervention Type OTHER

This is a cross-sectional study, no intervention was performed.

Interventions

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not intervention

This is a cross-sectional study, no intervention was performed.

Intervention Type OTHER

Other Intervention Names

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This is a cross-sectional study, no intervention was performed.

Eligibility Criteria

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Inclusion Criteria

* Survey Chinese participants with undiagnosed CAN
* Aged 30-90 years, were included in this study.

Exclusion Criteria

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zihui Tang

M.D and Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zihui Tang, M.D and Ph.D

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 25903694 (View on PubMed)

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.

Reference Type RESULT
PMID: 25594612 (View on PubMed)

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.

Reference Type RESULT
PMID: 25555369 (View on PubMed)

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.

Reference Type RESULT
PMID: 25287103 (View on PubMed)

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.

Reference Type RESULT
PMID: 24772443 (View on PubMed)

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.

Reference Type RESULT
PMID: 24633734 (View on PubMed)

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.

Reference Type RESULT
PMID: 24621478 (View on PubMed)

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.

Reference Type RESULT
PMID: 24360155 (View on PubMed)

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.

Reference Type RESULT
PMID: 23940593 (View on PubMed)

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.

Reference Type RESULT
PMID: 23902963 (View on PubMed)

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.

Reference Type RESULT
PMID: 23890865 (View on PubMed)

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.

Reference Type RESULT
PMID: 23770583 (View on PubMed)

Other Identifiers

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CANRA_Dr.Tang

Identifier Type: -

Identifier Source: org_study_id

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