Evaluation of Antithrombotic STrategies in STEMI Patients in China

STEMI Clinical Trial

— EAST-STEMI  

Official title:

Evaluation of Antithrombotic STrategies in STEMI Patients in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03510832
• Other study ID #: QLEmer201802
• Status: Enrolling by invitation
• First received: March 20, 2018
• Last updated: April 26, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2018
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8000
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergent PCI
• ST Elevation Myocardial Infarction
• STEMI

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (61)

Lead Sponsor

Collaborator

Qilu Hospital of Shandong University

Affiliated hospital of Taishan medical university, Affiliated Hospital of Weifang Medical University, Anhui Provincial Hospital, Binzhou Medical University Hospital, Central Hospital of Zibo, Chengyang People's Hospital, Dezhou People's Hospital, Dongying People's Hospital, Feicheng People's Hospital, Feixian People's Hospital, Henan Provincial Hospital, Heze Luxin Cardiovascular and Cerebrovascular Hospital, Heze Municipal Hospital, Inner Mongolia People's Hospital, Jinan Central Hospital Affiliated to Shandong University, Jining Integrative Medicine Hospital, Jining Medical University, JINING No.1 People's Hospital, Jinxiang People's Hospital, Laizhou City People's Hospital, Liaocheng People's Hospital, Linyi Central Hospital, Linyi People's Hospital, Linzi District People's Hospital, Longkou People's Hospital, Ningjin County People's Hospital, Peking University Care Luzhong Hospital, Pingdu People's Hospital, Qianfoshan Hospital, Qingdao Center Hospital, Qingdao Hiser Hospital, Qingdao Jiaozhou Central Hospital, Qingdao Municipal Hospital, Qingdao Westcoast New Area Central Hospital, Qingzhou People's Hospital, Shandong Provincial Hospital, Shengli Oilfield Central Hospital, Shouguang people's Hospital, Taian City Central Hospital, Tengzhou Central People's Hospital, The 5th People's Hospital of Jinan, The 6th People's Hospital of Jinan, The Affiliated Hospital of Qingdao University, The First Hospital of Zibo, The Second Hospital of Shandong University, The Second People's Hospital of Liaocheng, The Third Shandong Provincial Hospital, Tianjin Chest Hospital, Weifang People's Hospital, Weifang Traditional Chinese Hospital, Weihai Central Hospital, Weihai Municipal Hospital, Wenshang People's Hospital, Yantai Affiliated Hospital of Binzhou Medical University, Yantai Yuhuangding Hospital, Yantaishan Hospital, Yanzhou Branch of Affiliated Hospital of Jining Medical University, Yidu Central Hospital of Weifang, Yuncheng County People's Hospital, Zhouping People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years after emergent PCI
Secondary	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.	72 hours after contrast exposure
Secondary	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.	2 years after emergent PCI
Secondary	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.	2 years after emergent PCI
Secondary	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.	2 years after emergent PCI