Acute Myocardial InfarctionAMI-COPSNCT02737956
The Prognosis of Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Xinjiang Medical University at 1 site in China.
Trial summary
This study aims to establish a registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang, focusing on collecting comprehensive information including basic patient demographics, patient characteristics, diagnostic methods, treatment programs, and hospitalization outcomes such as… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 7,350 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2012to 10 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of acute myocardial infarction (AMI) patients hospitalized at the First Affiliated Hospital of Xinjiang Medical University. This includes individuals diagnosed with both acute ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI).
Who may be able to join
- Acute myocardial infarction patients in hospitalized of the First Affiliated Hospital of Xinjiang Medical University (include diagnosed acute ST-elevation or non ST-elevation myocardial infarction).Diagnosis criteria must meet Universal Definition for AMI (2012).
Who cannot join
- Combined with severe valvular heart disease;
- Combined with severe congenital heart disease;
- Combined hyperthyroidism, anemia and other high-powered heart disease;
- With pulmonary heart disease;
- With hypertrophic obstructive cardiomyopathy;
- Severe hypotension (SBP <90mmHg or DBP <60mmHg at enrollment);
Show all 17Show fewer
- Uncontrolled hypertension (SBP> 160 mmHg before PCI, and / or DBP> 100 mmHg);
- Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times);
- Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit);
- High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases;
- active peptic ulcer and skin ulcers;
- A patient who is allergic to clopidogrel, tegrellol, or aspirin;
- Patients with a history of cardiogenic shock within two weeks;
- pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age;
- In the past 3 months participated in other clinical researchers;
- Persons who do not have legal or legal competence;
- Any condition that the investigator considers unsuitable for participation in the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affilliatted Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
About this study
Official title: The Characteristics and Clinical Outcomes of Acute Myocardial Infarction
This study aims to establish a registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang, focusing on collecting comprehensive information including basic patient demographics, patient characteristics, diagnostic methods, treatment programs, and hospitalization outcomes such as mortality, treatment complications, hospitalization costs, and follow-up events (death, major adverse cardiac events). The goal is to identify and propose effective prevention strategies to reduce the incidence of AMI, optimize the management and outcomes of AMI patients by implementing guideline recommendations in clinical practice, and conduct analyses to develop effective treatment strategies and predictive models for clinical outcomes. This focus on Xinjiang aims to provide a comprehensive understanding of AMI within this specific geographic and demographic context, ultimately contributing to improved prevention, treatment, and management of AMI patients.
Read the detailed description
The objective of this study is to establish a comprehensive registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang. This platform is designed to support clinical research and translational medicine, aiming to improve the quality of AMI patient care through the integration of guideline recommendations into clinical practice. By collecting detailed information on patient demographics, characteristics, diagnostic methods, treatment programs, and outcomes, including mortality, complications, hospitalization costs, and follow-up events such as death and major adverse cardiac events, this study seeks to lay the foundation for future quality improvement initiatives and research. The ultimate goal is to translate research findings into improved care practices for AMI patients, thereby reducing morbidity and mortality associated with the condition. This endeavor will bridge the gap between clinical research and practical healthcare delivery, ensuring that advancements in the treatment and management of AMI directly benefit patients in Xinjiang, contributing to substantial improvements in healthcare outcomes.
- Conditions
- Acute Myocardial Infarction
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 |
|---|---|---|
| AMI patients with treatment of PCI | All the patiets treat with PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period. | |
| Medication | All the patiets treat with medication (standard secondary prevention) without PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All-cause mortality, Cardiac mortality
Measured: 5 years
Secondary outcomes (3)
Major adverse cardiovascular events (MACE)
Cardiac death, non-fatal myocardial infarction, and target vessel revascularization.
Measured: 5 years
Major adverse cardiovascular and cerebrovascular events (MACCE)
Cardiac death, non-fatal myocardial infarction, target vessel revascularization and stroke.
Measured: 5 years
stroke
ischemic stroke and hemorrhage
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 posted14 Apr 2016 (estimated)
- Study start1 Jun 2012
- Primary completion31 May 2016
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Retrospective
- Enrolment
- 7,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
- Investigators
- Xiang Xie, PhD, Principal investigator, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737956
- Sponsor's protocol ID
- 20160317-03
- Acronym
- AMI-COPS
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2016
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan J, Deng CJ, Wang SF, Aimaitijiang M, Wu TT, Zheng YY, Xie X, Ma YT. Predictive Value of the Modified GRACE Scoring System for All-Cause Mortality in Patients with Acute Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 6;24(6):161. doi: 10.31083/j.rcm2406161. eCollection 2023 Jun.
PubMed 39077519Xiu WJ, Yang HT, Zheng YY, Ma YT, Xie X. Delayed PCI 12 Hours after the Onset of Symptoms Is Associated with Improved Outcomes for Patients with ST-Segment Elevation Myocardial Infarction: A Real-World Study. J Interv Cardiol. 2019 Jun 18;2019:2387929. doi: 10.1155/2019/2387929. eCollection 2019.
PubMed 31772517
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics and Clinical Outcomes of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02737956
- Acronym / sponsor ID
- AMI-COPS / 20160317-03
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,350 participants (actual)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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 study aims to establish a registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang, focusing on collecting comprehensive information including basic patient demographics, patient characteristics, diagnostic methods, treatment programs, and hospitalization outcomes such as mortality, treatment complications, hospitalization costs, and follow-up events (death, major adverse cardiac events). The goal is to identify and propose effective prevention strategies to reduce the incidence of AMI, optimize the management and outcomes of AMI patients by implementing guideline recommendations in clinical practice, and conduct analyses to develop effective treatment strategies and predictive models for clinical outcomes. This focus on Xinjiang aims to provide a comprehensive understanding of AMI within this specific geographic and demographic context, ultimately contributing to improved prevention, treatment, and management of AMI patients.
Detailed description
The objective of this study is to establish a comprehensive registry and surveillance system for acute myocardial infarction (AMI) patients in Xinjiang. This platform is designed to support clinical research and translational medicine, aiming to improve the quality of AMI patient care through the integration of guideline recommendations into clinical practice. By collecting detailed information on patient demographics, characteristics, diagnostic methods, treatment programs, and outcomes, including mortality, complications, hospitalization costs, and follow-up events such as death and major adverse cardiac events, this study seeks to lay the foundation for future quality improvement initiatives and research. The ultimate goal is to translate research findings into improved care practices for AMI patients, thereby reducing morbidity and mortality associated with the condition. This endeavor will bridge the gap between clinical research and practical healthcare delivery, ensuring that advancements in the treatment and management of AMI directly benefit patients in Xinjiang, contributing to substantial improvements in healthcare outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMI patients with treatment of PCI | – | –All the patiets treat with PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period. |
| Medication | – | –All the patiets treat with medication (standard secondary prevention) without PCI were enrolled and recorded the clinical characteristic and outcomes during the follow-up period. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of acute myocardial infarction (AMI) patients hospitalized at the First Affiliated Hospital of Xinjiang Medical University. This includes individuals diagnosed with both acute ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI).
Key inclusion criteria (1 listed)
- Acute myocardial infarction patients in hospitalized of the First Affiliated Hospital of Xinjiang Medical University (include diagnosed acute ST-elevation or non ST-elevation myocardial infarction).Diagnosis criteria must meet Universal Definition for AMI (2012).
Key exclusion criteria (17 listed)
- Combined with severe valvular heart disease;
- Combined with severe congenital heart disease;
- Combined hyperthyroidism, anemia and other high-powered heart disease;
- With pulmonary heart disease;
- With hypertrophic obstructive cardiomyopathy;
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
Death
Time frame: 5 years
All-cause mortality, Cardiac mortality
3 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 5 years
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 5 years
stroke
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 39077519Yan J, Deng CJ, Wang SF, Aimaitijiang M, Wu TT, Zheng YY, Xie X, Ma YT. Predictive Value of the Modified GRACE Scoring System for All-Cause Mortality in Patients with Acute Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 6;24(6):161. doi: 10.31083/j.rcm2406161. eCollection 2023 Jun.
- Derived from this study: PubMed 31772517Xiu WJ, Yang HT, Zheng YY, Ma YT, Xie X. Delayed PCI 12 Hours after the Onset of Symptoms Is Associated with Improved Outcomes for Patients with ST-Segment Elevation Myocardial Infarction: A Real-World Study. J Interv Cardiol. 2019 Jun 18;2019:2387929. doi: 10.1155/2019/2387929. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Xiang Xie, PhD principal investigator
Xinjiang Medical 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 Xinjiang Medical 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 17 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: finished, as of the sponsor's last update on 28 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (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 NCT02737956, which also lists 2 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 28 Mar 2024.