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Cardiovascular Autonomic NeuropathyNCT02462616

Risk Analysis for Cardiovascular Autonomic Neuropathy

An observational study of Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Autonomic Neuropathy
What is being tested?
not intervention
How many people
2,100 participants
Where
1 siteChina
Study dates
Jan 2011to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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:
  • history or findings of arrhythmia and hyperthyroidism or hypothyroidism
  • pregnancy or lactation
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: The Risk Analysis for Cardiovascular Autonomic Neuropathy in General Chinese Population

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.

Read the 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.

Being tested
not intervention
Keywords
risk analysis, general Chinese population, cardiovascular autonomic neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • not interventionOther

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

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

Study groups in NCT02462616
Study groupRoleWhat they receive
Dr.Tang's research groupDr.Tang's research group for clinical risk analysis of human complex disease
Receives: Other: not intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiovascular autonomic neuropathy (CAN) measured by short-term heart rate variability (HRV)

    Measured: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
2,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462616
Sponsor's protocol ID
CANRA_Dr.Tang
Status last verified
Sep 2017
First submitted
26 May 2015
Last updated
6 Sep 2017
Results posted
No

Publications

  • 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.

    PubMed 25903694

  • 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.

    PubMed 25594612

  • 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.

    PubMed 25555369

  • 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.

    PubMed 25287103

  • 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.

    PubMed 24772443

  • 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.

    PubMed 24633734

  • 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.

    PubMed 24621478

  • 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.

    PubMed 24360155

  • 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.

    PubMed 23940593

  • 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.

    PubMed 23902963

  • 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.

    PubMed 23890865

  • 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.

    PubMed 23770583

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Autonomic Neuropathy, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiovascular autonomic neuropathy (CAN) measured by short-term heart rate variability (HRV) (time frame: participants will be measured for the duration of outpatient stay, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462616, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

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