Acute Myocardial InfarctionSAVINGNCT06489080
Survival and cArdiovascular eVents in Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction and Coronary Artery Disease, run by Peking University First Hospital at 1 site in China.
Trial summary
This prospective and prospective cohort study aims to establish a long-term follow-up cohort of patients with acute myocardial infarction, and combine multi-omics studies, wearable devices, artificial intelligence technology, etc., to describe the clinical characteristics of patients with acute myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2028
- How long will I take part?
- 5 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the department of Cardiology or outpatient department of Peking University First Hospital will be enrolled if they are aged ≥18 years old, meet the inclusion criteria of acute myocardial infarction and need long-term follow-up according to the judgment of doctors after informed consent. There are about 7500 retrospectively enrolled patients, and it is expected to enroll 500 patients per year.
Who may be able to join
- Acute myocardial infarction is diagnosed meets the universal definition of acute myocardial infarction
Who cannot join
- Did not agree to participate in the study
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
Division of Cardiology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jia Jia, 861083572283, jiajia9985@163.com
About this study
Official title: Survival and cArdiovascular eVents in Patients With Acute Myocardial Infarction in Peking UNiversity First Hospital: A lonG-term Cohort Study
This prospective and prospective cohort study aims to establish a long-term follow-up cohort of patients with acute myocardial infarction, and combine multi-omics studies, wearable devices, artificial intelligence technology, etc., to describe the clinical characteristics of patients with acute myocardial infarction and the changing trend of treatment strategies, and analyze the related influencing factors. Explore new biomarkers and indicators affecting recurrent cardiovascular events for accurate risk stratification and risk prediction; To evaluate the factors affecting lifestyle intervention, drug efficacy and safety, and their impact on outcome, and improve chronic disease management mode, in order to improve the quality of life and prognosis of patients.
- Keywords
- Acute Myocardial Infarction, Coronary Artery Disease, cohort study
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Composite end points of Cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke
Measured: 5 years
Secondary outcomes (1)
Secondary Adverse Cardiovascular Events
All-cause death, non-cardiac death, myocardial infarction, hospitalization for coronary revascularization, hospitalization for heart failure, hospitalization for acute coronary syndrome, ischemic stroke, hemorrhagic stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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 Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping LI, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489080
- Sponsor's protocol ID
- 2024yan097-002
- Acronym
- SAVING
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.
PubMed 24969506Xu H, Yang Y, Wang C, Yang J, Li W, Zhang X, Ye Y, Dong Q, Fu R, Sun H, Yan X, Gao X, Wang Y, Jia X, Sun Y, Wu Y, Zhang J, Zhao W, Sabatine MS, Wiviott SD; China Acute Myocardial Infarction Registry Investigators. Association of Hospital-Level Differences in Care With Outcomes Among Patients With Acute ST-Segment Elevation Myocardial Infarction in China. JAMA Netw Open. 2020 Oct 1;3(10):e2021677. doi: 10.1001/jamanetworkopen.2020.21677.
PubMed 33095249Hao Y, Zhao D, Liu J, Liu J, Yang N, Huo Y, Fonarow GC, Ge J, Morgan L, Ma C, Han Y, Smith SC Jr; CCC-ACS Investigators. Performance of Management Strategies With Class I Recommendations Among Patients Hospitalized With ST-Segment Elevation Myocardial Infarction in China. JAMA Cardiol. 2022 May 1;7(5):484-491. doi: 10.1001/jamacardio.2022.0117.
PubMed 35293976
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and cArdiovascular eVents in Patients With Acute Myocardial Infarction in Peking UNiversity First Hospital: A lonG-term Cohort Study
- ClinicalTrials.gov ID
- NCT06489080
- Acronym / sponsor ID
- SAVING / 2024yan097-002
- Keywords
- Acute Myocardial Infarction, Coronary Artery Disease, cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jul 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.
This prospective and prospective cohort study aims to establish a long-term follow-up cohort of patients with acute myocardial infarction, and combine multi-omics studies, wearable devices, artificial intelligence technology, etc., to describe the clinical characteristics of patients with acute myocardial infarction and the changing trend of treatment strategies, and analyze the related influencing factors. Explore new biomarkers and indicators affecting recurrent cardiovascular events for accurate risk stratification and risk prediction; To evaluate the factors affecting lifestyle intervention, drug efficacy and safety, and their impact on outcome, and improve chronic disease management mode, in order to improve the quality of life and prognosis of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the department of Cardiology or outpatient department of Peking University First Hospital will be enrolled if they are aged ≥18 years old, meet the inclusion criteria of acute myocardial infarction and need long-term follow-up according to the judgment of doctors after informed consent. There are about 7500 retrospectively enrolled patients, and it is expected to enroll 500 patients per year.
Key inclusion criteria (1 listed)
- Acute myocardial infarction is diagnosed meets the universal definition of acute myocardial infarction
Key exclusion criteria (1 listed)
- Did not agree to participate in the study
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: 5 years
Composite end points of Cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke
1 secondary outcome
Secondary Adverse Cardiovascular Events
Time frame: 5 years
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 5 Jul 2024.
- Background: PubMed 24969506Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.
- Background: PubMed 33095249Xu H, Yang Y, Wang C, Yang J, Li W, Zhang X, Ye Y, Dong Q, Fu R, Sun H, Yan X, Gao X, Wang Y, Jia X, Sun Y, Wu Y, Zhang J, Zhao W, Sabatine MS, Wiviott SD; China Acute Myocardial Infarction Registry Investigators. Association of Hospital-Level Differences in Care With Outcomes Among Patients With Acute ST-Segment Elevation Myocardial Infarction in China. JAMA Netw Open. 2020 Oct 1;3(10):e2021677. doi: 10.1001/jamanetworkopen.2020.21677.
- Background: PubMed 35293976Hao Y, Zhao D, Liu J, Liu J, Yang N, Huo Y, Fonarow GC, Ge J, Morgan L, Ma C, Han Y, Smith SC Jr; CCC-ACS Investigators. Performance of Management Strategies With Class I Recommendations Among Patients Hospitalized With ST-Segment Elevation Myocardial Infarction in China. JAMA Cardiol. 2022 May 1;7(5):484-491. doi: 10.1001/jamacardio.2022.0117.
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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 Acute Myocardial Infarction and Coronary Artery Disease, run by Peking University First Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 5 Jul 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 Jia Jia, MPH (861083572283, jiajia9985@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: 5 years). 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 NCT06489080, 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 5 Jul 2024.