STEMIEAST-STEMINCT03510832
Evaluation of Antithrombotic STrategies in STEMI Patients in China
An observational study of STEMI and Emergent PCI, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Emergent PCI
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive STEMI patients undergoing emergent PCI
Who may be able to join
- Age>=18yrs
- STEMI patients undergoing emergent PCI
- Signed informed consent
Who cannot join
- Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
- Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)
Trial locations and contacts
1 site in 1 country.
About this study
EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. Novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.
- Conditions
- STEMI, Emergent PCI
- Medical subject headings
- ST Elevation 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 |
|---|---|---|
| STEMI patients undergoing Emergent PCI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Events (NACEs)
The primary outcome is the rate of adjudicated NACEs, a composite of major adverse cardiac or cerebral events (MACCEs) and bleeding. MACCEs include cardiac death, reinfarction, urgent revascularization, or stroke. Bleeding is defined by the Bleeding Academic Research Consortium (BARC) definition (types 1-5). BARC type 2 bleeding is considered as minor bleeding, type 3-5 bleeding is considered as major bleeding.
Measured: 2 years after emergent PCI
Secondary outcomes (4)
Contrast-induced acute kidney injury (CI-AKI)
CI-AKI is defined as an increase in serum creatinine of ≥0.3mg/dl or ≥50% from baseline within 72 hours.
Measured: 72 hours after contrast exposure
Definite/Probable Stent thrombosis
Stent thrombosis is defined according to the Academic Research Consortium criteria. Definite stent thrombosis is defined as angiography or autopsy examination confirmed stent occlusion or thrombus. Probable stent thrombosis is defined as death occurring within 30 days that cannot be attributed to another cause or when myocardial infarction occurs at any time point and is attributable to the target vessel in the absence of angiography confirming another culprit lesion.
Measured: 2 years after emergent PCI
Heart failure
Heart failure is defined as physician documentation or report of any of the following clinical symptoms of heart failure described as unusual dyspnea on light exertion, recurrent dyspnea occurring in the supine position, fluid retention; or the description of rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray. A low ejection fraction alone, without clinical evidence of heart failure does not qualify as heart failure.
Measured: 2 years after emergent PCI
Quality of life (QoL)
QoL is assessed by using EuroQol-5 Dimension (EQ-5D), which is the most widely used generic instrument to measure QoL. The utility index scores of EQ-5D represent the QoL.The higher the score, the better the QoL.
Measured: 2 years after emergent PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (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 STEMIStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- 8,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Jinan Central Hospital, The Second Hospital of Shandong University, Shandong Province Third hospital, The 5th People's Hospital of Jinan, The 6th People's Hospital of Jinan, The Affiliated Hospital of Qingdao University, Qingdao Municipal Hospital, Qingdao Central Hospital, Qingdao Haici Hospital, Chengyang People's Hospital, Qingdao Westcoast New Area Central Hospital, Qingdao Jiaozhou Central Hospital, Pingdu People's Hospital, Central Hospital of Zibo, Zibo First Hospital, Linzi District People's Hospital, Peking University Care Luzhong Hospital, Tengzhou Central People's Hospital, Dongying People's Hospital, Shengli Oilfield Hospital, Yantaishan Hospital, Yantai Yuhuangding Hospital, Yantai Affiliated Hospital of Binzhou Medical University, Longkou People's Hospital, Laizhou City People's Hospital, Weifang People's Hospital, Weifang Medical University, Weifang Traditional Chinese Medicine Hospital, Weifang Yidu Central Hospital, Qingzhou People's Hospital, Shouguang People's Hospital, Jining Medical University, Jining First People's Hospital, Wenshang People's Hospital, Affiliated Hospital of Jining Medical University, Jinxiang People's Hospital, Taian City Central Hospital, Taishan Medical University Affiliated Hospital, Feicheng People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Binzhou Medical University, Zhouping People's Hospital, Dezhou People's Hospital, Ningjin County People's Hospital, Liaocheng People's Hospital, The Second People's Hospital of Liaocheng, Linyi People's Hospital, Feixian People's Hospital, Heze Municipal Hospital, Yuncheng County People's Hospital, Heze Luxin Cardiovascular and Cerebrovascular Hospital, Jining Integrative Medicine Hospital, Tianjin Chest Hospital, Henan Provincial People's Hospital, Inner Mongolia People's Hospital, Anhui Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Dr, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510832
- Sponsor's protocol ID
- QLEmer201802
- Acronym
- EAST-STEMI
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu S, Wang S, Xu F, Pang J, Chen Y. High Kidney Function in Myocardial Infarction Patients Who Underwent Coronary Intervention: Acute Kidney Injury Risk and Long-term Prognosis. Can J Cardiol. 2026 Apr 13:S0828-282X(26)00354-5. doi: 10.1016/j.cjca.2026.04.001. Online ahead of print.
PubMed 41985625
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antithrombotic STrategies in STEMI Patients in China
- ClinicalTrials.gov ID
- NCT03510832
- Acronym / sponsor ID
- EAST-STEMI / QLEmer201802
- Conditions
- STEMI, Emergent PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Jinan Central Hospital, The Second Hospital of Shandong University, Shandong Province Third hospital, The 5th People's Hospital of Jinan, The 6th People's Hospital of Jinan, The Affiliated Hospital of Qingdao University, Qingdao Municipal Hospital, Qingdao Central Hospital, Qingdao Haici Hospital, Chengyang People's Hospital, Qingdao Westcoast New Area Central Hospital, Qingdao Jiaozhou Central Hospital, Pingdu People's Hospital, Central Hospital of Zibo, Zibo First Hospital, Linzi District People's Hospital, Peking University Care Luzhong Hospital, Tengzhou Central People's Hospital, Dongying People's Hospital, Shengli Oilfield Hospital, Yantaishan Hospital, Yantai Yuhuangding Hospital, Yantai Affiliated Hospital of Binzhou Medical University, Longkou People's Hospital, Laizhou City People's Hospital, Weifang People's Hospital, Weifang Medical University, Weifang Traditional Chinese Medicine Hospital, Weifang Yidu Central Hospital, Qingzhou People's Hospital, Shouguang People's Hospital, Jining Medical University, Jining First People's Hospital, Wenshang People's Hospital, Affiliated Hospital of Jining Medical University, Jinxiang People's Hospital, Taian City Central Hospital, Taishan Medical University Affiliated Hospital, Feicheng People's Hospital, Weihai Municipal Hospital, Weihai Central Hospital, Binzhou Medical University, Zhouping People's Hospital, Dezhou People's Hospital, Ningjin County People's Hospital, Liaocheng People's Hospital, The Second People's Hospital of Liaocheng, Linyi People's Hospital, Feixian People's Hospital, Heze Municipal Hospital, Yuncheng County People's Hospital, Heze Luxin Cardiovascular and Cerebrovascular Hospital, Jining Integrative Medicine Hospital, Tianjin Chest Hospital, Henan Provincial People's Hospital, Inner Mongolia People's Hospital, Anhui Provincial Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Apr 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.
EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. Novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients undergoing Emergent PCI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive STEMI patients undergoing emergent PCI
Key inclusion criteria (3 listed)
- Age>=18yrs
- STEMI patients undergoing emergent PCI
- Signed informed consent
Key exclusion criteria (2 listed)
- Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
- Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)
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
Net Adverse Clinical Events (NACEs)
Time frame: 2 years after emergent PCI
The primary outcome is the rate of adjudicated NACEs, a composite of major adverse cardiac or cerebral events (MACCEs) and bleeding. MACCEs include cardiac death, reinfarction, urgent revascularization, or stroke. Bleeding is defined by the Bleeding Academic Research Consortium (BARC) definition (types 1-5). BARC type 2 bleeding is considered as minor bleeding, type 3-5 bleeding is considered as major bleeding.
4 secondary outcomes
Contrast-induced acute kidney injury (CI-AKI)
Time frame: 72 hours after contrast exposure
Definite/Probable Stent thrombosis
Time frame: 2 years after emergent PCI
Heart failure
Time frame: 2 years after emergent PCI
Quality of life (QoL)
Time frame: 2 years after emergent PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Derived from this study: PubMed 41985625Wu S, Wang S, Xu F, Pang J, Chen Y. High Kidney Function in Myocardial Infarction Patients Who Underwent Coronary Intervention: Acute Kidney Injury Risk and Long-term Prognosis. Can J Cardiol. 2026 Apr 13:S0828-282X(26)00354-5. doi: 10.1016/j.cjca.2026.04.001. Online ahead of print.
- 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. This study is not recruiting at the moment.
Yuguo Chen, Dr principal investigator
Qilu Hospital of Shandong 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 STEMI and Emergent PCI, run by Qilu Hospital of Shandong 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 3 inclusion and 2 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 27 Apr 2018. 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?
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?
Net Adverse Clinical Events (NACEs) (time frame: 2 years after emergent PCI). 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 NCT03510832, 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 27 Apr 2018.