Evaluation of Antithrombotic STrategies in STEMI Patients in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03510832

Acronym

EAST-STEMI

Enrollment

8000

Registered

2018-04-27

Start date

2018-03-01

Completion date

2021-12-31

Last updated

2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergent PCI, STEMI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

China

Outcome results