ACS (Acute Coronary Syndrome)AMI-YouthNCT07128667
Clinical Features and Long-Term Prognosis in Young Patients With Acute Myocardial Infarction
An observational study of ACS (Acute Coronary Syndrome) and Young Adults, run by China-Japan Friendship Hospital.
Trial summary
The incidence of acute myocardial infarction (AMI) in young patients is on the rise, placing a heavy health and economic burden on individuals, families, and society. The clinical phenotype and pathophysiological mechanisms of AMI in this population exhibit significant heterogeneity compared to elderly patients, and… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACS (Acute Coronary Syndrome), Young Adults
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2028
- How long will I take part?
- 2 Years
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population for this project primarily consists of patients aged 18 to 45 years (inclusive) with acute myocardial infarction (AMI). These patients meet the diagnostic criteria for either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) and presented for medical attention within 24 hours of symptom onset.
Who may be able to join
- Age between 18 and 45 years (inclusive of 18 and 45 years);
- Meeting the diagnostic criteria for acute myocardial infarction (including both ST-elevation myocardial infarction and non-ST-elevation myocardial infarction);
- Presenting for medical attention within 24 hours of symptom onset;
- The subject (or their legal representative) is willing and able to sign the informed consent form (for the prospective follow-up portion);
- Life expectancy greater than 1 year.
Who cannot join
- (1) History of prior old myocardial infarction, severe valvular heart disease, or heart failure; (2) Pregnancy or lactation; (3) Mental disorders or other conditions that prevent cooperation with treatment; (4) Concomitant severe infection, inflammatory or immunological biomarker changes unrelated to AMI, trauma, or recent major surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Cohort Study on Clinical Characteristics, Risk Factors, and Long-Term Outcomes in Young Patients With Acute Myocardial Infarction
The incidence of acute myocardial infarction (AMI) in young patients is on the rise, placing a heavy health and economic burden on individuals, families, and society. The clinical phenotype and pathophysiological mechanisms of AMI in this population exhibit significant heterogeneity compared to elderly patients, and existing risk assessment tools have limited applicability in this specific group. The core problem this study aims to address is: how to accurately identify specific risk factors in young AMI patients and build an effective risk prediction model to prevent and optimize clinical diagnosis and treatment.
This study will adopt a prospective cohort design to collect multi-dimensional clinical data from young AMI patients. It will systematically analyze their clinical characteristics, risk factors, and coronary lesion status to comprehensively map the clinical, risk factor, and pathophysiological diversity of young AMI patients. Secondly, it will delve into identifying specific risk factors that influence the onset, progression, and long-term prognosis of young AMI. Thirdly, it will combine machine learning algorithms to develop a risk prediction model for young AMI, performing internal validation in the prospective cohort and external validation in the MIMIC-IV database. Simultaneously, it will explore novel biomarkers associated with disease onset and progression. The key outcomes of this study are to establish a high-quality clinical database of young AMI patients, design a risk prediction model for young AMI based on the study results, and produce high-level academic publications.
- Conditions
- ACS (Acute Coronary Syndrome), Young Adults
- Keywords
- acute myocardial infarction, young adults, prognosis, risk factors
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant arrhythmia events
Measured: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
All-cause mortality
Measured: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
Non-fatal myocardial infarction
Measured: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS (Acute Coronary Syndrome)Studies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengqin Zhai, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128667
- Sponsor's protocol ID
- 2025-08-12
- Acronym
- AMI-Youth
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Clinical Characteristics, Risk Factors, and Long-Term Outcomes in Young Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07128667
- Acronym / sponsor ID
- AMI-Youth / 2025-08-12
- Conditions
- ACS (Acute Coronary Syndrome), Young Adults
- Keywords
- acute myocardial infarction, young adults, prognosis, risk factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Aug 2025 (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 acute myocardial infarction (AMI) in young patients is on the rise, placing a heavy health and economic burden on individuals, families, and society. The clinical phenotype and pathophysiological mechanisms of AMI in this population exhibit significant heterogeneity compared to elderly patients, and existing risk assessment tools have limited applicability in this specific group. The core problem this study aims to address is: how to accurately identify specific risk factors in young AMI patients and build an effective risk prediction model to prevent and optimize clinical diagnosis and treatment.
This study will adopt a prospective cohort design to collect multi-dimensional clinical data from young AMI patients. It will systematically analyze their clinical characteristics, risk factors, and coronary lesion status to comprehensively map the clinical, risk factor, and pathophysiological diversity of young AMI patients. Secondly, it will delve into identifying specific risk factors that influence the onset, progression, and long-term prognosis of young AMI. Thirdly, it will combine machine learning algorithms to develop a risk prediction model for young AMI, performing internal validation in the prospective cohort and external validation in the MIMIC-IV database. Simultaneously, it will explore novel biomarkers associated with disease onset and progression. The key outcomes of this study are to establish a high-quality clinical database of young AMI patients, design a risk prediction model for young AMI based on the study results, and produce high-level academic publications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population for this project primarily consists of patients aged 18 to 45 years (inclusive) with acute myocardial infarction (AMI). These patients meet the diagnostic criteria for either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) and presented for medical attention within 24 hours of symptom onset.
Key inclusion criteria (5 listed)
- Age between 18 and 45 years (inclusive of 18 and 45 years);
- Meeting the diagnostic criteria for acute myocardial infarction (including both ST-elevation myocardial infarction and non-ST-elevation myocardial infarction);
- Presenting for medical attention within 24 hours of symptom onset;
- The subject (or their legal representative) is willing and able to sign the informed consent form (for the prospective follow-up portion);
- Life expectancy greater than 1 year.
Key exclusion criteria (1 listed)
- (1) History of prior old myocardial infarction, severe valvular heart disease, or heart failure; (2) Pregnancy or lactation; (3) Mental disorders or other conditions that prevent cooperation with treatment; (4) Concomitant severe infection, inflammatory or immunological biomarker changes unrelated to AMI, trauma, or recent major surgery.
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
Malignant arrhythmia events
Time frame: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
All-cause mortality
Time frame: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
Non-fatal myocardial infarction
Time frame: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).
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 19 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS (Acute Coronary Syndrome) and Young Adults, run by China-Japan Friendship Hospital.
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 5 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhengqin Zhai, Dr (+86 18612511571, zhengqin712@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignant arrhythmia events (time frame: Short-term endpoints (in-hospital and within 30 days post-discharge).Long-term endpoints (12 months post-discharge).). 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 19 Aug 2025.