Myocardial Infarction, AcuteTAMINCT03600259
Tianjin Inpatient Acute Myocardial Infarction Registry
An observational study of Myocardial Infarction, Acute, run by Tianjin Chest Hospital at 1 site in China.
Trial summary
Acute myocardial infarction(AMI) is the most serious manifestation of coronary artery disease. AMI is characterized by high mortality, high disability, and high cost. However, multicenter research on AMI with large sample size in Tianjin or even China is limited. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 13,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2023
- 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: Hospitalized patients with acute myocardial infarction from 36 hospitals in Tianjin were enrolled between January 2015 and January 2020
Who may be able to join
- Hospitalized patients with acute myocardial infarction according to Cardiac biomarker values [Selective cardiac troponin (cTc) elevation and/or decline detection, at least one value exceeds the 99% reference limit (URL) and at least one of the following:（1）Symptoms of myocardial ischemia；（2）New or suspected new obvious ST-T changes or new left bundle branch block (LBBB)；（3）ECG pathological Q waves；（4）Image evidence of recent loss of viable myocardium, or new regional wall motion abnormalities；（5）Coronary thrombosis confirmed by angiography or autopsy.]
Who cannot join
- Those who did not meet the diagnosis of acute myocardial infarction (no myocardial ischemia-related symptoms, elevation of markers of myocardial necrosis and imaging findings of myocardial infarction); those who met the inclusion criteria but refused to participate in the study; The researchers judged that the subjects had poor compliance and could not Complete follow-up as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Yin Liu, M.D., +86-13502152283, tami2018@163.com
About this study
Official title: Cohort Study of Acute Myocardial Infarction in Tianjin
Acute myocardial infarction(AMI) is the most serious manifestation of coronary artery disease. AMI is characterized by high mortality, high disability, and high cost. However, multicenter research on AMI with large sample size in Tianjin or even China is limited. By including AMI in 36 hospitals,this multicenter study will capture the changes in epidemiological trends ,analyze the status of treatment in Tianjin, and explore the best treatment strategies.
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Myocardial Infarction, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia
- Medical subject headings
- Myocardial Infarction, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Myocardial Infarction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Due to recent cardiac causes (eg myocardial infarction, low-volume heart failure, fatal arrhythmias), any deaths from unknown and unexplained deaths and all surgical-related deaths (including treatment-related deaths) will be attributed to cardiac death.Unless there is a clear non-cardiological cause, all deaths are considered heart disease. Specifically, even patients with concurrent potentially fatal non-cardiac diseases (such as cancer, infections) who have any accidental death should be classified as having a heart attack.
Measured: 1 year
Secondary outcomes (5)
Major adverse cardiovascular events
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
Measured: 10 days on average (during hospitalization)
Major adverse cardiovascular events
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
Measured: 1 month
Major adverse cardiovascular events
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
Measured: 3 months
Major adverse cardiovascular events
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
Measured: 6 months
Major adverse cardiovascular events
Composite of major adverse cardiovascular events (MACE) including cardiac death, heart failure, target vessel revascularization, recurrent myocardial infarction, stroke, severe bleeding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Dec 2023 (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 Myocardial Infarction, AcuteStudies 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
- Other
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Liu,MD, Tianjin Chest Hospital
- Investigators
- Yin Liu, M.D, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600259
- Sponsor's protocol ID
- TAMI20180705
- Acronym
- TAMI
- Status last verified
- Nov 2022
- First submitted
- 6 Jul 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao MD, Zhang EY, Liu YY, Li XW, Xiao JY, Sun GY, Liu Y. Intracoronary pressure gradient measurement in acute myocardial infarction patients with the no-reflow phenomenon during primary percutaneous coronary intervention. Chin Med J (Engl). 2020 Apr 5;133(7):766-772. doi: 10.1097/CM9.0000000000000709.
PubMed 32149760
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Acute Myocardial Infarction in Tianjin
- ClinicalTrials.gov ID
- NCT03600259
- Acronym / sponsor ID
- TAMI / TAMI20180705
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Myocardial Infarction, Coronary Disease, Coronary Artery Disease, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Jul 2018 (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.
Acute myocardial infarction(AMI) is the most serious manifestation of coronary artery disease. AMI is characterized by high mortality, high disability, and high cost. However, multicenter research on AMI with large sample size in Tianjin or even China is limited. By including AMI in 36 hospitals,this multicenter study will capture the changes in epidemiological trends ,analyze the status of treatment in Tianjin, and explore the best treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Myocardial Infarction | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients with acute myocardial infarction from 36 hospitals in Tianjin were enrolled between January 2015 and January 2020
Key inclusion criteria (1 listed)
- Hospitalized patients with acute myocardial infarction according to Cardiac biomarker values [Selective cardiac troponin (cTc) elevation and/or decline detection, at least one value exceeds the 99% reference limit (URL) and at least one of the following:（1）Symptoms of myocardial ischemia；（2）New or suspected new obvious ST-T changes or new left bundle branch block (LBBB)；（3）ECG pathological Q waves；（4）Image evidence of recent loss of viable myocardium, or new regional wall motion abnormalities；（5）Coronary thrombosis confirmed by angiography or autopsy.]
Key exclusion criteria (1 listed)
- Those who did not meet the diagnosis of acute myocardial infarction (no myocardial ischemia-related symptoms, elevation of markers of myocardial necrosis and imaging findings of myocardial infarction); those who met the inclusion criteria but refused to participate in the study; The researchers judged that the subjects had poor compliance and could not Complete follow-up as required.
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
Cardiac death
Time frame: 1 year
Due to recent cardiac causes (eg myocardial infarction, low-volume heart failure, fatal arrhythmias), any deaths from unknown and unexplained deaths and all surgical-related deaths (including treatment-related deaths) will be attributed to cardiac death.Unless there is a clear non-cardiological cause, all deaths are considered heart disease. Specifically, even patients with concurrent potentially fatal non-cardiac diseases (such as cancer, infections) who have any accidental death should be classified as having a heart attack.
5 secondary outcomes
Major adverse cardiovascular events
Time frame: 10 days on average (during hospitalization)
Major adverse cardiovascular events
Time frame: 1 month
Major adverse cardiovascular events
Time frame: 3 months
Major adverse cardiovascular events
Time frame: 6 months
Major adverse cardiovascular events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 32149760Gao MD, Zhang EY, Liu YY, Li XW, Xiao JY, Sun GY, Liu Y. Intracoronary pressure gradient measurement in acute myocardial infarction patients with the no-reflow phenomenon during primary percutaneous coronary intervention. Chin Med J (Engl). 2020 Apr 5;133(7):766-772. doi: 10.1097/CM9.0000000000000709.
- Individual participant dataSharing planned: Undecided
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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.
Yin Liu, M.D principal investigator
Tianjin Chest 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 Myocardial Infarction, Acute, run by Tianjin Chest 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Yin Liu, M.D (+86-13502152283, tami2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death (time frame: 1 year). 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 NCT03600259, 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 2 Nov 2022.