NCT06663267

Brief Summary

The goal of this observational study is to analyze the acute effects of meteorological factors and air pollution on cardiovascular system. The main question it aims to answer is:

  1. 1.How do meteorological factors and air pollution affect cardiovascular system?
  2. 2.What is the interaction between meteorological factors and air pollution on cardiovascular system?
  3. 3.Provide their health data obtained in physical examination, including but not limited to blood pressure, blood routine, urine routine and B-ultrasound.
  4. 4.agree that the research team will use their personal identification number, gender, age, education level and other information for statistical analysis of the data.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350,000

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Nov 2024May 2028

First Submitted

Initial submission to the registry

May 12, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

May 12, 2024

Last Update Submit

October 26, 2024

Conditions

Keywords

Cardiovascular SystemAir Pollution ExposureAcute effectWeather

Outcome Measures

Primary Outcomes (2)

  • Troponin

    Troponin data were obtained by blood biochemical detection data recorded in the diagnosis and treatment system, with unit of µg/L.

    The troponin data were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • Blood pressure

    Blood pressure data were obtained from the diagnosis and treatment record system and analyzed by standard sphygmomanometer, with unit of mmHg.

    The blood pressure data were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

Secondary Outcomes (8)

  • Left ventricular ejection fraction(LVEF)

    The left ventricular ejection fraction(LVEF)data were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • White cell count

    The white cell count data were tested at baseline 3 months before exposure to meteorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • Controlled Attenuation Parameter(CAP)

    The Controlled Attenuation Parameter(CAP)data were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • ST segment of electrocardiogram

    The ST segment of electrocardiogram were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • Degree of coronary artery stenosis

    The degree of coronary artery stenosis data were tested at baseline 3 months before exposure tometeorological factors or air pollution, and followed up for 1 year and 2 years after exposure.

  • +3 more secondary outcomes

Study Arms (4)

High Temperature Group

Participants experiencing temperatures above the 90th percentile for the region, as recorded during the summer months. Temperature data are sourced from local meteorological statio

Other: NOT

Low Temperature Group

Includes participants from areas where winter temperatures are below the 10th percentile, based on historical weather data from local meteorological observations

Other: NOT

High Pollution Group

Participants in this group are those exposed to high levels of air pollutants

Other: NOT

Low Pollution Group

This cohort consists of individuals living in areas with air pollutant levels consistently below the national air quality standards

Other: NOT

Interventions

NOTOTHER

This retrospective cohort study involves no new interventions. It analyzes existing health data collected from subjects exposed to varying atmospheric conditions to assess impacts on health outcomes.

High Pollution GroupHigh Temperature GroupLow Pollution GroupLow Temperature Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Target population: adults who have been recorded at least three times in the physical examination database will be included in this study. This requirement aims to ensure that the participants\' health status can be fully evaluated historically, and then to study the changes of various health indicators over time. 2. Sample source and recruitment: Participants will be selected from the routine physical examination database of several hospital physical examination centers in Zhejiang, Henan, Anhui, Guizhou and other provinces.

You may qualify if:

  • ·Relevant records in the physical examination database shall be ≥3 times
  • ·≥18 years old

You may not qualify if:

  • Relevant records in the physical examination database shall be ≥3times
  • Serious heart and lung diseases
  • Malignant tumors
  • Serious mental illness in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MingWei Wang

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

  • Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.

    PMID: 12802026BACKGROUND
  • McCarron P, Smith GD, Okasha M, McEwen J. Blood pressure in young adulthood and mortality from cardiovascular disease. Lancet. 2000 Apr 22;355(9213):1430-1. doi: 10.1016/S0140-6736(00)02146-2.

    PMID: 10791531BACKGROUND
  • Tandon S, Grande AJ, Karamanos A, Cruickshank JK, Roever L, Mudway IS, Kelly FJ, Ayis S, Harding S. Association of Ambient Air Pollution with Blood Pressure in Adolescence: A Systematic-review and Meta-analysis. Curr Probl Cardiol. 2023 Feb;48(2):101460. doi: 10.1016/j.cpcardiol.2022.101460. Epub 2022 Oct 18.

    PMID: 36265590BACKGROUND

Central Study Contacts

Mingwei W Wang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2024

First Posted

October 29, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations