Evaluation of Antithrombotic STrategies in STEMI Patients in China

• Conditions: Emergent PCI; STEMI

• Registration Number: NCT03510832
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-01
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study First Posted: 2018-04-27
• Last Update Posted: 2018-04-27
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Events (NACEs)	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life (QoL)	2 years after emergent PCI	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.
Contrast-induced acute kidney injury (CI-AKI)	72 hours after contrast exposure	CI-AKI is defined as an increase in serum creatinine of ≥0.3mg/dl or ≥50% from baseline within 72 hours.
Definite/Probable Stent thrombosis	2 years after emergent PCI	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.
Heart failure	2 years after emergent PCI	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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China