Evaluation of Antithrombotic STrategies in STEMI Patients in China (EAST-STEMI)

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 Overview

• Status: Unknown
• Conditions: STEMI; Emergent PCI

• Study Type: Observational
• Enrollment (Anticipated): 8000

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive STEMI patients undergoing emergent PCI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
STEMI patients undergoing Emergent PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (ACTUAL): April 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: QLEmer201802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No