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Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy

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ClinicalTrials.gov Identifier: NCT02461342
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Huashan Hospital
Information provided by (Responsible Party):
Zihui Tang, Huashan Hospital

Brief Summary:
A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions 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 variables of genetic, environment were collected. Every participants was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.

Condition or disease Intervention/treatment
Cardiovascular Autonomic Neuropathy Other: not intervention

Detailed Description:
A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions 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 variables of genetic, environment were collected. Every participant was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN.

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Study Type : Observational
Actual Enrollment : 2100 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy in Chinese Population
Study Start Date : January 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Group/Cohort Intervention/treatment
Dr.Tang's research group
Dr.Tang's research group for genetic, environment and its interaction analysis of human complex disease
Other: not intervention
This is a cross-sectional study, no intervention was performed.
Other Name: nothing




Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
DNAs were extracted and genetyped by using SNP.


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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461342


Locations
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China, Shanghai
Huasha Hospital
Shanghai, Shanghai, China, 200040
Huashan Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Huashan Hospital
Investigators
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Principal Investigator: Zihui Tang, M.D and Ph.D Huashan Hospital

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zihui Tang, M.D and Ph.D, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02461342     History of Changes
Other Study ID Numbers: CANGEI_Dr.Tang
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Zihui Tang, Huashan Hospital:
Genetic
environment
interaction analysis
cardiovascular autonomic neuropathy
CAN
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases