Acute Coronary SyndromeAPCIcohortNCT05719545
A Cohort of Patients Undergoing Percutaneous Coronary Intervention
An observational study of Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Su Guohai at 1 site in China.
Trial summary
To investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Myocardial Infarction
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Who may be able to join
- Diagnosed as acute coronary syndrome and needed to undergo percutaneous coronary intervention.
- >18 years old.
Who cannot join
- With malignant tumors, acute 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
Jinan Central Hospital
Jinan, Shandong
Guohai Su, doctor, +86-18854125717, huangrong9277@163.com
About this study
Official title: A Longitudinal Cohort of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
To investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years.
Read the detailed description
Patients with acute coronary syndrome undergoing percutaneous coronary intervention 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. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as diagnosis, medical history, laboratory test results, therapy methods, prognosis and follow-up information. The risk factors involved in the occurrence and prognosis of acute coronary syndrome will be investigated.
- Conditions
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Myocardial Infarction, Unstable Angina
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable
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
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 posted9 Feb 2023
- Study start1 Dec 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Su Guohai
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong First Medical University
- Responsible party
- Sponsor-investigator, Su Guohai, Jinan Central Hospital
- Investigators
- Guohao Su, doctor, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719545
- Sponsor's protocol ID
- 2021-206-02
- Acronym
- APCIcohort
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05719545
- Acronym / sponsor ID
- APCIcohort / 2021-206-02
- Conditions
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Myocardial Infarction, Unstable Angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Su GuohaiUniversity, hospital or other
- Collaborators
- Shandong First Medical University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Feb 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 investigate the risk factors involved in the occurrence and prognosis of the patients with acute coronary syndrome, patients undergoing percutaneous coronary intervention will be recruited and followed up for at least 2 years.
Detailed description
Patients with acute coronary syndrome undergoing percutaneous coronary intervention 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. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as diagnosis, medical history, laboratory test results, therapy methods, prognosis and follow-up information. The risk factors involved in the occurrence and prognosis of acute coronary syndrome will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Key inclusion criteria (2 listed)
- Diagnosed as acute coronary syndrome and needed to undergo percutaneous coronary intervention.
- >18 years old.
Key exclusion criteria (2 listed)
- With malignant tumors, acute 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
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 9 Feb 2023.
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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.
Guohao Su, doctor principal investigator
Jinan Central Hospital
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 Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Su Guohai 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 9 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 Guohai Su, doctor (+86-18854125717, 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 9 Feb 2023.