Acute Myocardial InfarctionNCT04451967
Acute Myocardial Infarction Study in Northeastern China
An observational study of Acute Myocardial Infarction, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
This is a real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- thrombolysis
- Type of treatment
- Surgery or procedure
- How many people
- 3,159 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2019to 9 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)
Who may be able to join
- patients admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction (2018)
Who cannot join
- Types 4a and type 5 AMI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second hospital of Jilin university
Changchun, Jilin, 130041
He Wang, Doctor, 043188796625, wanghe221@163.com
About this study
Official title: the Acute Myocardial Infarction Study in Northeastern China
This is a real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).
- Conditions
- Acute Myocardial Infarction
- Being tested
- thrombolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombolysisProcedure or surgery
Also called DAPT
transfer after thrombolysis for STEMI patients within 6h since onset
| Study group | Role | What they receive |
|---|---|---|
| Transfer after thrombolysis | Not described Receives: Procedure: thrombolysis | |
| Transfer after DAPT | Not described | |
| Direct transfer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
all-cause death
Measured: 2 years post discharge
Secondary outcomes (1)
major adverse cardiac events (MACE)
recurrent angina, non-fatal myocardial infarction, cardiac failure, malignant arrhythmia, and death from cardiovascular causes
Measured: 2 years post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start9 Sep 2019
- Primary completion9 Sep 2020 (estimated)
- Study completion9 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- 3,159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Yanbian University Hospital, Dunhua City Hospital in Jilin Province, Liaoyuan City Central Hospital, Dongliao People's Hospital, Songyuan Central Hospital, Changling People's Hospital, Siping Central People's Hospital, The First People's Hospital of Manchu Autonomous County, Changchun Center Hospital, Nongan People's Hospital, Beihua University, Jilin Hospital of Integrated Traditional Chinese and Western Medicine, Panshi City Hospital, Tonghua Central Hospital, Baishan Central Hospital, Jingyu People's Hospital, Meihekou Central Hospital, Baicheng Central Hospital, Tongyu First Hospital
- Responsible party
- Sponsor
- Investigators
- Bin Liu, Ph.D, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451967
- Sponsor's protocol ID
- SecondJilinU-AMINoC
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li T, Wu J, Liu J, Sun W, Qi C, Liu B, Wells GA, Wang J; Acute Myocardial Infarction Study in Northeastern China (AMINoC). Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study. BMJ Open. 2021 May 25;11(5):e042936. doi: 10.1136/bmjopen-2020-042936.
PubMed 34035090
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Acute Myocardial Infarction Study in Northeastern China
- ClinicalTrials.gov ID
- NCT04451967
- Acronym / sponsor ID
- SecondJilinU-AMINoC
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,159 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Yanbian University Hospital, Dunhua City Hospital in Jilin Province, Liaoyuan City Central Hospital, Dongliao People's Hospital, Songyuan Central Hospital, Changling People's Hospital, Siping Central People's Hospital, The First People's Hospital of Manchu Autonomous County, Changchun Center Hospital, Nongan People's Hospital, Beihua University, Jilin Hospital of Integrated Traditional Chinese and Western Medicine, Panshi City Hospital, Tonghua Central Hospital, Baishan Central Hospital, Jingyu People's Hospital, Meihekou Central Hospital, Baicheng Central Hospital, Tongyu First Hospital
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 9 Sep 2020 (estimated)
- Study completion
- 9 Sep 2022 (estimated)
- First posted
- 30 Jun 2020 (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 is a real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transfer after thrombolysis | – | Procedure: thrombolysis |
| Transfer after DAPT | – | – |
| Direct transfer | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)
Key inclusion criteria (1 listed)
- patients admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction (2018)
Key exclusion criteria (1 listed)
- Types 4a and type 5 AMI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombolysisAlso: DAPTtransfer after thrombolysis for STEMI patients within 6h since onset | Procedure or surgery | Transfer after thrombolysis |
Primary outcome
all-cause death
Time frame: 2 years post discharge
all-cause death
1 secondary outcome
major adverse cardiac events (MACE)
Time frame: 2 years post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 34035090Li T, Wu J, Liu J, Sun W, Qi C, Liu B, Wells GA, Wang J; Acute Myocardial Infarction Study in Northeastern China (AMINoC). Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study. BMJ Open. 2021 May 25;11(5):e042936. doi: 10.1136/bmjopen-2020-042936.
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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.
Bin Liu, Ph.D principal investigator
Second Hospital of Jilin 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 Acute Myocardial Infarction, run by Second Hospital of Jilin 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 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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 Tianyi Li, Ph.D (+8615843024731, litianyi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 2 years post discharge). 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 NCT04451967, which also lists 1 linked publication.
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 30 Jun 2020.