Acute Myocardial InfarctionNCT05121818
Prospective Acute Myocardial Infarction Data Bank
An observational study of Acute Myocardial Infarction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with acute myocardial infarction will be enrolled into the study based on the inclusion/exclusion criteria. No randomisation will be performed.
Who may be able to join
- Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy.
Who cannot join
- life expectancy of less than 12 months
- malignant tumor
- pregnancy or plans of pregnancy in the one year
- any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Creation of a Prospective Acute Myocardial Infarction Data Bank
In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai，including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital，Shanghai Tenth People's Hospital，Shanghai First People's Hospital, and Shanghai Tongji Hospital.
- Conditions
- Acute Myocardial Infarction
- Being tested
- PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Primary percutaneous coronary intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of patients with acute myocardial infarction
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 posted16 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121818
- Sponsor's protocol ID
- ZSMI21
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 16 Nov 2021
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Prospective Acute Myocardial Infarction Data Bank
- ClinicalTrials.gov ID
- NCT05121818
- Acronym / sponsor ID
- ZSMI21
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Nov 2021 (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.
In order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. All data are from patients treated in 5 centers in Shanghai，including Zhongshan Hospital of Fudan University, Shanghai Renji Hospital，Shanghai Tenth People's Hospital，Shanghai First People's Hospital, and Shanghai Tongji Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction will be enrolled into the study based on the inclusion/exclusion criteria. No randomisation will be performed.
Key inclusion criteria (1 listed)
- Acute myocardial infarction was diagnosed based on the Fourth Universal Definition of Acute myocardial infarction criteria. The term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: Symptoms of myocardial ischaemia; New ischaemic ECG changes; Development of pathological Q waves; Imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; Identification of a coronary thrombus by angiography or autopsy.
Key exclusion criteria (4 listed)
- life expectancy of less than 12 months
- malignant tumor
- pregnancy or plans of pregnancy in the one year
- any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling
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 |
|---|---|---|
| PCIPrimary percutaneous coronary intervention | Procedure or surgery | – |
Primary outcome
Database of patients with acute myocardial infarction
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 16 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shanghai Zhongshan 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 4 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 16 Nov 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database of patients with acute myocardial infarction (time frame: 5 years). 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 16 Nov 2021.