Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study (ELITISM)

Ya-Wei Xu

Status: Completed

Conditions: Left Ventricular Diastoic Dysfunction Cohort Study

Treatments: Other: Diuretic，Betaloc，antiplatelet drugs

Study type: Observational

Funder types: Other

Identifiers

NCT03735251

ELITISM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,920 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,920 participants in 1 patient group

Left Ventricular Diastoic Dysfunction Classification

Description:

normal diastole pattern：E/A\>1，DT 160\~220 ms，S/D \>1，AR 0.22-0.32m/sec，E/e'\< 8 diastolic dysfunction pattern 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

Treatment:

Other: Diuretic，Betaloc，antiplatelet drugs