Coronary Heart DiseaseNCT05699629
Prospective Coronary Heart Disease Cohort
An observational study of Coronary Heart Disease and Myocardial Infarction, run by Shandong First Medical University at 1 site in China.
Trial summary
To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Myocardial Infarction
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2022to 21 Jan 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with coronary heart diseases undergoing coronary angiography and healthy control subjects undergoing routine physical examination in physical examination department.
Who may be able to join
- Diagnosed as coronary heart disease or with unexplained chest pain needed to undergo coronary angiography.
- Healthy subjects undergoing routine physical examination in the physical examination department and willing to sign informed consent will be recruited as control subjects.
Who cannot join
- With malignant tumors, infectious diseases and advanced liver diseases.
- Won't sign an inform consent.
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
Shandong First Medical University
Jinan, Shandong, 277500
Rong Huang, Dr.
About this study
Official title: A Prospective Longitudinal Multi-Omics Cohort of Patients With Coronary Heart Disease Undergoing Coronary Angiography
To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years.
Read the detailed description
Patients with cardiovascular disease undergoing coronary angiography will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as socio-demographic, diet, lifestyle, psychological status and medical history. The biomarkers for the incidence of coronary heart disease and the factors contributing to the poor prognosis of coronary heart disease will be investigated based on multi-omics analysis.
- Conditions
- Coronary Heart Disease, Myocardial Infarction
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events
all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization
Measured: 2-year outcome and long-term outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start21 Jan 2022
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong First Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital, Shandong Provincial Hospital, The Second Affiliated Hospital of Shandong First Medical University, Qianfoshan Hospital
- Responsible party
- Sponsor
- Investigators
- Tao Xu, Dr., Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699629
- Sponsor's protocol ID
- 2021-206-02
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Multi-Omics Cohort of Patients With Coronary Heart Disease Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT05699629
- Acronym / sponsor ID
- 2021-206-02
- Conditions
- Coronary Heart Disease, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Shandong First Medical UniversityUniversity, hospital or other
- Collaborators
- Jinan Central Hospital, Shandong Provincial Hospital, The Second Affiliated Hospital of Shandong First Medical University, Qianfoshan Hospital
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 26 Jan 2023 (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.
To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years.
Detailed description
Patients with cardiovascular disease undergoing coronary angiography will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as socio-demographic, diet, lifestyle, psychological status and medical history. The biomarkers for the incidence of coronary heart disease and the factors contributing to the poor prognosis of coronary heart disease will be investigated based on multi-omics analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart diseases undergoing coronary angiography and healthy control subjects undergoing routine physical examination in physical examination department.
Key inclusion criteria (2 listed)
- Diagnosed as coronary heart disease or with unexplained chest pain needed to undergo coronary angiography.
- Healthy subjects undergoing routine physical examination in the physical examination department and willing to sign informed consent will be recruited as control subjects.
Key exclusion criteria (2 listed)
- With malignant tumors, infectious diseases and advanced liver diseases.
- Won't sign an inform consent.
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
major adverse cardiovascular events
Time frame: 2-year outcome and long-term outcome
all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization
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 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Tao Xu, Dr. study chair
Shandong First Medical 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 and Myocardial Infarction, run by Shandong First Medical 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 2 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 13 Feb 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?
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 Rong Huang, Dr. (18854125717, huangrong9277@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (time frame: 2-year outcome and long-term outcome). 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 13 Feb 2023.