Clinical trial NCT03510832: Evaluation of Antithrombotic STrategies in STEMI Patients in China
Official title: Evaluation of Antithrombotic STrategies in STEMI Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Emergent PCI
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Qianfoshan Hospital
name: Jinan Central Hospital
name: The Second Hospital of Shandong University
name: Shandong Province Third hospital
name: The 5th People's Hospital of Jinan
name: The 6th People's Hospital of Jinan
name: The Affiliated Hospital of Qingdao University
name: Qingdao Municipal Hospital
name: Qingdao Central Hospital
name: Qingdao Haici Hospital
name: Chengyang People's Hospital
name: Qingdao Westcoast New Area Central Hospital
name: Qingdao Jiaozhou Central Hospital
name: Pingdu People's Hospital
name: Central Hospital of Zibo
name: Zibo First Hospital
name: Linzi District People's Hospital
name: Peking University Care Luzhong Hospital
name: Tengzhou Central People's Hospital
name: Dongying People's Hospital
name: Shengli Oilfield Hospital
name: Yantaishan Hospital
name: Yantai Yuhuangding Hospital
name: Yantai Affiliated Hospital of Binzhou Medical University
name: Longkou People's Hospital
name: Laizhou City People's Hospital
name: Weifang People's Hospital
name: Weifang Medical University
name: Weifang Traditional Chinese Hospital
name: Yidu Central Hospital of Weifang
name: Qingzhou People's Hospital
name: Shouguang people's Hospital
name: Jining Medical University
name: Jining First People's Hospital
name: Wenshang People's Hospital
name: Yanzhou Branch of Affiliated Hospital of Jining Medical University
name: Jinxiang People's Hospital
name: Taian City Central Hospital
name: Taishan Medical University Affiliated Hospital
name: Feicheng People's Hospital
name: Weihai Municipal Hospital
name: Weihai Central Hospital
name: Binzhou Medical University
name: Zhouping People's Hospital
name: Dezhou People's Hospital
name: Ningjin County People's Hospital
name: Liaocheng People's Hospital
name: The Second People's Hospital of Liaocheng
name: Linyi People's Hospital
name: Feixian People's Hospital
name: Heze Municipal Hospital
name: Yuncheng County People's Hospital
name: Heze Luxin Cardiovascular and Cerebrovascular Hospital
name: Jining Integrative Medicine Hospital
name: Tianjin Chest Hospital
name: Henan Provincial People's Hospital
name: Inner Mongolia People's Hospital
name: Anhui Provincial Hospital
First posted: 2018-04-27
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive STEMI patients undergoing emergent PCI

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age\>=18yrs
2. STEMI patients undergoing emergent PCI
3. Signed informed consent

Exclusion Criteria:

1. Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
2. Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)

Primary outcomes:
measure: Net Adverse Clinical Events (NACEs)
timeFrame: 2 years after emergent PCI
Secondary outcomes:
measure: Contrast-induced acute kidney injury (CI-AKI)
timeFrame: 72 hours after contrast exposure
measure: Definite/Probable Stent thrombosis
timeFrame: 2 years after emergent PCI
measure: Heart failure
timeFrame: 2 years after emergent PCI
measure: Quality of life (QoL)
timeFrame: 2 years after emergent PCI
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yuguo Chen, Dr
role: PRINCIPAL_INVESTIGATOR
References: