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Completed

NCT Number: NCT02462616

Risk Analysis for Cardiovascular Autonomic Neuropathy

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

not intervention

Other

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

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Other

Collaborators

  • Huashan Hospital

Registry information

Official study title

The Risk Analysis for Cardiovascular Autonomic Neuropathy in General Chinese Population

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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