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

NCT ID: NCT03735251

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1920 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-10
• Study Completion Date: 2014-08-10

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.

Conditions

Left Ventricular Diastoic Dysfunction Cohort Study

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Left Ventricular Diastoic Dysfunction Classification

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

Diuretic，Betaloc，antiplatelet drugs

Intervention Type: OTHER

According to international guidelines,we treated patinets who suffered from different disease

Interventions

Diuretic，Betaloc，antiplatelet drugs

According to international guidelines,we treated patinets who suffered from different disease

Intervention Type: OTHER

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ya-Wei Xu

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Shanghai 10th People's Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

ELITISM

Identifier Type: -

Identifier Source: org_study_id