Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,920
- Primary Endpoint
- left ventricular diastolic dysfunction
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 55 years or more
- •informed consent should be signed voluntarily
- •local residents from communities in northern Shanghai and available for long-term follow-up
Exclusion Criteria
- •was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
- •suffered from cancer or his/her life expectancy is <5 years
- •had stroke within 3 months
- •is not willing to participate in the clinical study
- •has to quit the trial due to other diseases
- •violates the protocol or loses contact with the laboratory staff.
Outcomes
Primary Outcomes
left ventricular diastolic dysfunction
Time Frame: From July 2014 to August 2019
All the ultrasonography measurements are performed with a MyLab 30 CV machine (ESAOTE SpA, Genoa, Italy), according to the American Society of Echocardiography (ASE) recommendations.The echocardiography is performed in the left decubitus position. Left ventricular (LV) internal diameter at end-diastole (LVIDd) and septal (SWTd) and posterior wall thickness at end-diastole (PWTd) are measured directly. left ventricular diastolic dysfunction including: Impaired relaxation pattern：E/A\< 1，DT \> 220 ms，S/D \> 1，AR 0.21-0.28 m/sec，E/e'\<10 Pseudo-normalization pattern：E/A\> 1，DT 150\~210 ms，S/D \< 1，AR ≥0.35m/sec，E/e'≥ 10 Restrictive pattern：E/A ≥ 2，DT \< 150 ms，S/D \<1，AR ≥0.25m/sec，E/e'≥10
Secondary Outcomes
No secondary outcomes reported
Investigators
Ya-Wei Xu
Shanghai 10th People's Hospital
Shanghai 10th People's Hospital