Clinical trial NCT03735251: Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
Official title: Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Diastoic Dysfunction Cohort Study
Keywords: Left Ventricular Diastoic Dysfunction Cohort study
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 1920
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Northern Shanghai region has the largest population of elderly adults in Shanghai, with a total population of 1.57 million and an elderly proportion of over 19%. We use a computer-generated list of communities, and 10 communities were randomly selected for the first-phase enrolment. Other communities in the list will be randomly selected for the later enrolment. According to the inclusion and exclusion criteria, we invite all the eligible older people (over 55 years) to participate in this study. The recruitment strategies include: (1) posting study recruitment files in the neighbourhood committees and community hospitals; (2) according to the health file, community hospitals recruit the potential participants Open Accessby telephone; (3) hand out recruitment flyers directly to the potential participants.

Brief summary: This study is one of the largest ongoing prospective population studies to evaluate target organ damages (TODs) and Left Ventricular Diastoic Dysfunction in the community-dwelling elderly Chinese, which is authorised and funded by the Shanghai municipal government.This study was approved by the Shanghai Tenth People's Hospital Institutional Review Board and was conducted under financial support from the Shanghai municipal government (grant ID: 2013ZYJB0902 and 15GWZK1002). The preliminary sample size is expected to be 3000-4000 participants.

Detailed description: The Northern Shanghai Study is an ongoing prospective community-based study. After enrolment, clinical examination,anthropometric measurement and a questionnaire will be administered to each participant at baseline and patients will be followed up every six months. Our tests and examinations include: blood/urine sample and biochemical measurements, office blood pressure recording, carotid ultrasonograph, echocardiograph, pulse wave velocity, pulse wave analysis, 4-limb blood pressure recording, body mass index, etc. Baseline measurement will also include the assessments on target organ damages(TODs) and the conventional CV risk factors. In the follow-up, the incidence of CV events and mortality will be recorded. The Northern Shanghai Risk Score will be calculated, with considerations on CV risk factors and TODs.

Eligibility criteria: Inclusion Criteria:

1. age 55 years or more
2. informed consent should be signed voluntarily
3. local residents from communities in northern Shanghai and available for long-term follow-up

Exclusion Criteria:

1. was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
2. suffered from cancer or his/her life expectancy is \<5 years
3. had stroke within 3 months
4. is not willing to participate in the clinical study
5. has to quit the trial due to other diseases
6. violates the protocol or loses contact with the laboratory staff.

Primary outcomes:
measure: left ventricular diastolic dysfunction
timeFrame: From July 2014 to August 2019
Secondary outcomes:
Other outcomes:
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Study officials:
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