Cardiovascular SystemNCT06663267
Acute Effects of Meteorological Factors and Air Pollution on Cardiovascular Health
An observational study of Cardiovascular System and Health, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
Trial 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. How do meteorological factors and air pollution affect cardiovascular system? 2. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular System, Health
- What is being tested?
- NOT
- How many people
- 350,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ·Relevant records in the physical examination database shall be ≥3 times
- ·≥18 years old
Who cannot join
- Relevant records in the physical examination database shall be ≥３times
- Serious heart and lung diseases
- Malignant tumors
- Serious mental illness in the past
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
MingWei Wang
Hanzhou, Zhejiang, 310000
MingWei W Wang, PhD, 86-18758871517 ext. NOT, wmw990556@163.com
About this study
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.
Read the 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.
- Conditions
- Cardiovascular System, Health
- Being tested
- NOT
- Keywords
- Cardiovascular System, Air Pollution Exposure, Acute effect, Weather
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: NOT | |
| High Pollution Group | Participants in this group are those exposed to high levels of air pollutants Receives: Other: NOT | |
| Low Pollution Group | This cohort consists of individuals living in areas with air pollutant levels consistently below the national air quality standards Receives: Other: NOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin
Troponin data were obtained by blood biochemical detection data recorded in the diagnosis and treatment system, with unit of µg/L.
Measured: 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.
Measured: 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）
Left ventricular ejection fraction（LVEF）data were obtained by Cardiac color ultrasound data recorded in the diagnosis and treatment system, with unit of %
Measured: 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
White cell count data were obtained by blood routine blood data recorded in the diagnosis and treatment system, with unit of 10^9/L
Measured: 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）
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.
Measured: 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
ST segment were obtained by Electrocardiogram (ECG) recorded in the diagnosis and treatment system with unit of mV.
Measured: 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
Degree of coronary artery stenosis data were obtained by Coronary CTA data recorded in the diagnosis and treatment system, with unit of µg/L
Measured: 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
Weight data were obtained from the diagnosis and treatment record system and recorded by standard measuring tools, with unit of kg
Measured: 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
Height data were obtained from the diagnosis and treatment record system and recorded by standard measuring tools, with unit of cm
Measured: 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
Urinary glucose data were obtained by Urine routine data recorded in the diagnosis and treatment system, with unit of mmol/L.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663267
- Sponsor's protocol ID
- AH-2023-005
- Status last verified
- Oct 2024
- First submitted
- 12 May 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 12802026McCarron 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.
PubMed 10791531Tandon 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.
PubMed 36265590
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Meteorological Factors and Air Pollution on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT06663267
- Acronym / sponsor ID
- AH-2023-005
- Conditions
- Cardiovascular System, Health
- Keywords
- Cardiovascular System, Air Pollution Exposure, Acute effect, Weather
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350,000 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Temperature Group | – | Other: NOTParticipants experiencing temperatures above the 90th percentile for the region, as recorded during the summer months. Temperature data are sourced from local meteorological statio |
| Low Temperature Group | – | Other: NOTIncludes participants from areas where winter temperatures are below the 10th percentile, based on historical weather data from local meteorological observations |
| High Pollution Group | – | Other: NOTParticipants in this group are those exposed to high levels of air pollutants |
| Low Pollution Group | – | Other: NOTThis cohort consists of individuals living in areas with air pollutant levels consistently below the national air quality standards |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ·Relevant records in the physical examination database shall be ≥3 times
- ·≥18 years old
Key exclusion criteria (4 listed)
- Relevant records in the physical examination database shall be ≥３times
- Serious heart and lung diseases
- Malignant tumors
- Serious mental illness in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOTThis 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. | Other | High Pollution Group, High Temperature Group, Low Pollution Group, Low Temperature Group |
Primary outcome
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.
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.
8 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 12802026Clement 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.
- Background: PubMed 10791531McCarron 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.
- Background: PubMed 36265590Tandon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular System and Health, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingwei W Wang, PhD (18758871517 ext. not, wmw990556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663267, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.