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

NCT03735251 | Completed DMC

• 1 other identifier: ELITISM
• Study Type: observational
• Target: 1,920
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Left Ventricular Diastoic Dysfunction Cohort Study

Keywords

Left Ventricular Diastoic Dysfunction Cohort study

Outcome Measures

Primary Outcomes (1)

• left ventricular diastolic dysfunction

  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

  From July 2014 to August 2019

Study Arms (1)

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

Other: Diuretic，Betaloc，antiplatelet drugs

Interventions

Diuretic，Betaloc，antiplatelet drugs OTHER

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

Left Ventricular Diastoic Dysfunction Classification

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ya-Wei Xu: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples are obtained after an overnight fast. Total cholesterol, high-density lipoprotein cholesterol and triglycerides are measured by standard methods, and the Friedewald formula is used to calculate the lowdensity lipoprotein (LDL) cholesterol (LDL-c). Other biological parameters like plasma/urine albumin and creatinine are measured by standard methods at local laboratories. The urine albumin-to-creatinine ratio (UACR) is also calculated. The serum and urine samples will be stored at -80°C. Prior to storage, the date, number of vials and recorder's name will be recorded.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai 10th People's Hospital

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: July 10, 2014
• Primary Completion: July 10, 2014
• Study Completion: August 10, 2014
• Last Updated: April 26, 2021

Record last verified: 2014-07