- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06663267
Acute Effects of Meteorological Factors and Air Pollution on Cardiovascular Health
October 26, 2024 updated by: The Affiliated Hospital of Hangzhou Normal University
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:
- How do meteorological factors and air pollution affect cardiovascular system?
- What is the interaction between meteorological factors and air pollution on cardiovascular system?
Participants will:
- Provide their health data obtained in physical examination, including but not limited to blood pressure, blood routine, urine routine and B-ultrasound.
- agree that the research team will use their personal identification number, gender, age, education level and other information for statistical analysis of the data.
Study Overview
Detailed Description
The collected data include: ID number (or unique identification code similar to ID number), physical examination date, work unit, occupation, gender, age, systolic blood pressure, diastolic blood pressure, height, weight, blood routine, urine routine and blood biochemical examination results,Color Doppler (or B-ultrasound) examination results (thyroid color Doppler, abdominal color Doppler, urinary color Doppler, cardiac color Doppler, cervical vascular color Doppler, etc.), electrocardiogram, cardiac CTA, carbon 13 breath test, and written diagnosis results of liver fibrosis.
Study Type
Observational
Enrollment (Estimated)
350000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mingwei W Wang, PhD
- Phone Number: not 18758871517
- Email: wmw990556@163.com
Study Locations
-
-
Zhejiang
-
Hanzhou, Zhejiang, China, 310000
- Recruiting
- MingWei Wang
-
Contact:
- MingWei W Wang, PhD
- Phone Number: NOT 86-18758871517
- Email: wmw990556@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- 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.
- 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.
Description
Inclusion Criteria:
·Relevant records in the physical examination database shall be ≥3 times
·≥18 years old
Exclusion Criteria:
- Relevant records in the physical examination database shall be ≥3times
- Serious heart and lung diseases
- Malignant tumors
- Serious mental illness in the past
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
|
Low Temperature Group
Includes participants from areas where winter temperatures are below the 10th percentile, based on historical weather data from local meteorological observations
|
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 Group
Participants in this group are those exposed to high levels of air pollutants
|
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.
|
|
Low Pollution Group
This cohort consists of individuals living in areas with air pollutant levels consistently below the national air quality standards
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Troponin
Time Frame: 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.
|
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
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left ventricular ejection fraction(LVEF)
Time Frame: 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.
|
Left ventricular ejection fraction(LVEF)data were obtained by Cardiac color ultrasound data recorded in the diagnosis and treatment system, with unit of %
|
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
Time Frame: 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.
|
White cell count data were obtained by blood routine blood data recorded in the diagnosis and treatment system, with unit of 10^9/L
|
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)
Time Frame: 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.
|
Controlled Attenuation Parameter(CAP)data were obtained by Diagnosis of hepatic fibrosis data recorded in the diagnosis and treatment system, with unit of dB/m.
|
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
Time Frame: 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.
|
ST segment were obtained by Electrocardiogram (ECG) recorded in the diagnosis and treatment system with unit of mV.
|
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
Time Frame: 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.
|
Degree of coronary artery stenosis data were obtained by Coronary CTA data recorded in the diagnosis and treatment system, with unit of µg/L
|
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.
|
|
Weight
Time Frame: The weight 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.
|
Weight data were obtained from the diagnosis and treatment record system and recorded by standard measuring tools, with unit of kg
|
The weight 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.
|
|
Height
Time Frame: The height 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.
|
Height data were obtained from the diagnosis and treatment record system and recorded by standard measuring tools, with unit of cm
|
The height 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.
|
|
Urinary glucose
Time Frame: The urinary glucose 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.
|
Urinary glucose data were obtained by Urine routine data recorded in the diagnosis and treatment system, with unit of mmol/L.
|
The urinary glucose 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2028
Study Registration Dates
First Submitted
May 12, 2024
First Submitted That Met QC Criteria
October 26, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 26, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- AH-2023-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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