Coronary Heart DiseaseNCT05175495
Influencing Factors of Coronary Heart Disease in Young People
An observational study of Coronary Heart Disease, run by Hongzhuan Sheng at 1 site in China.
Trial summary
The incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Diagnosed coronary heart disease
Who may be able to join
- Diagnosed coronary heart disease
- Confirmed by coronary angiography
- Diagnosed myocardial infarction
- Willing to sign an inform consent
Who cannot join
- Patients won't sign an inform consent or will not comply with the follow up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
shengHz
Nantong, Jiangsu, 226000
HZ S, Dr., 13515203348, yjshz@ntu.edu.cn
H L, A master's degree, 18351328050, 898571711@qq.com
About this study
Official title: To Study the Risk Factors of Youth Coronary Heart Disease From Inflammatory Cytokines，Lifestyle and Familial Inheritance
The incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome
Read the detailed description
Through the multi-center clinical research conducted by several units in Nantong city, the risk factors and aggregation of the incidence of CHD among young people in nantong city were obtained, so as to fill in the blank of domestic multi-center research and reduce the incidence of CHD among young people.The investigators will conduct a long-term follow-up study on the young patients with CHD to screen the factors contributing to the poor prognosis of CHD in young patients.The investigators will fill this gap and intervene early to improve patients' quality of life and prolong their survival
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, Inflammatory cytokines, lifestyle, Familial inheritance, Myocardial infarction
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal young | Aged less than 45 years old,no underlying heart disease | |
| Young people diagnosed with coronary heart disease | Aged less than 45 years old,Diagnosed coronary heart disease;Confirmed by coronary angiography;Diagnosed myocardial infarction;Typical symptom of ischemic chest pain with positive stress test; | |
| Coronary heart disease | Older than 65 years, diagnosed with coronary heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether inflammatory factors are differentially expressed in young patients with coronary heart disease
The Investigators will analyze blood samples from the participants to see if there was a difference in the expression of inflammatory factors with high correlation compared with the control group by ELESA and High-throughput sequencing.
Measured: Until April 2024
The effect of gene activity on youth morbidity
The investigators will use enrichment analysis to screen the target genes and sequence the participants.Whether the target gene was expressed at high levels in the participants.And the investigators will further analyze the target gene
Measured: Until April 2024
Sedentary, high-fat diet, lack of exercise and other unhealthy lifestyle effects on young people
The researchers will retrospectively examine the participants' negative lifestyle habits, such as sedentary behavior, smoking, high-fat diet, and lack of exercise, in combination with their coronary angiography results
Measured: Until April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Aug 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongzhuan Sheng
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University
- Responsible party
- Sponsor-investigator, Hongzhuan Sheng, Affiliated Hospital of Nantong University
- Investigators
- hzh sheng, Dr., Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175495
- Sponsor's protocol ID
- Observational
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share our findings with you when the 2024 project is due
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Risk Factors of Youth Coronary Heart Disease From Inflammatory Cytokines，Lifestyle and Familial Inheritance
- ClinicalTrials.gov ID
- NCT05175495
- Acronym / sponsor ID
- Observational
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, Inflammatory cytokines, lifestyle, Familial inheritance, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hongzhuan ShengUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 3 Jan 2022 (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 incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome
Detailed description
Through the multi-center clinical research conducted by several units in Nantong city, the risk factors and aggregation of the incidence of CHD among young people in nantong city were obtained, so as to fill in the blank of domestic multi-center research and reduce the incidence of CHD among young people.The investigators will conduct a long-term follow-up study on the young patients with CHD to screen the factors contributing to the poor prognosis of CHD in young patients.The investigators will fill this gap and intervene early to improve patients' quality of life and prolong their survival
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal young | – | –Aged less than 45 years old,no underlying heart disease |
| Young people diagnosed with coronary heart disease | – | –Aged less than 45 years old,Diagnosed coronary heart disease;Confirmed by coronary angiography;Diagnosed myocardial infarction;Typical symptom of ischemic chest pain with positive stress test; |
| Coronary heart disease | – | –Older than 65 years, diagnosed with coronary heart disease |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Diagnosed coronary heart disease
Key inclusion criteria (4 listed)
- Diagnosed coronary heart disease
- Confirmed by coronary angiography
- Diagnosed myocardial infarction
- Willing to sign an inform consent
Key exclusion criteria (1 listed)
- Patients won't sign an inform consent or will not comply with the follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether inflammatory factors are differentially expressed in young patients with coronary heart disease
Time frame: Until April 2024
The Investigators will analyze blood samples from the participants to see if there was a difference in the expression of inflammatory factors with high correlation compared with the control group by ELESA and High-throughput sequencing.
The effect of gene activity on youth morbidity
Time frame: Until April 2024
The investigators will use enrichment analysis to screen the target genes and sequence the participants.Whether the target gene was expressed at high levels in the participants.And the investigators will further analyze the target gene
Sedentary, high-fat diet, lack of exercise and other unhealthy lifestyle effects on young people
Time frame: Until April 2024
The researchers will retrospectively examine the participants' negative lifestyle habits, such as sedentary behavior, smoking, high-fat diet, and lack of exercise, in combination with their coronary angiography results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No. We will share our findings with you when the 2024 project is due
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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. This study is not recruiting at the moment.
hzh sheng, Dr. study chair
Affiliated Hospital of Nantong University
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 Coronary Heart Disease, run by Hongzhuan Sheng 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hzh sheng, Dr. (13515203348, yjshz@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether inflammatory factors are differentially expressed in young patients with coronary heart disease (time frame: Until April 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.