Risk Analysis for Cardiovascular Autonomic Neuropathy

Completed

• Conditions: Cardiovascular Autonomic Neuropathy
• Interventions: Other: not intervention

• Registration Number: NCT02462616
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dr.Tang's research group	not intervention	Dr.Tang's research group for clinical risk analysis of human complex disease

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China