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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03735251
Acronym
ELITISM
Enrollment
1920
Registered
2018-11-08
Start date
2014-07-10
Completion date
2014-08-10
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Diastoic Dysfunction Cohort Study

Keywords

Left Ventricular Diastoic Dysfunction Cohort study

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.

Interventions

OTHERDiuretic,Betaloc,antiplatelet drugs

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

Sponsors

Ya-Wei Xu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
left ventricular diastolic dysfunctionFrom July 2014 to August 2019All 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026