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NCT02830217 Clinical Trial

Evaluation of Soluble ST2 in Patients Receiving Primary PCI With ST-elevation Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:
Using Soluble ST2 to Predict Clinical Outcomes in Patients Receiving Primary Percutaneous Coronary Intervention With ST-elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02830217
Other study ID # 2016LMC-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2015
Est. completion date December 20, 2018

Study information
Verified date October 2019
Source Wuhan Asia Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients are readmitted shortly after the primary PCI for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. This study is intended to test the predictive ability of a new biomarker soluble ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. This study will further investigate the ability of sST2 to predict unfavorable outcomes for STEMI patients after primary PCI.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 20, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with first onset STEMI receive primary PCI according to 2013 ACCF/AHA guideline for management of STEMI

Exclusion Criteria:

- Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Wuhan Asia Heart Hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary stent restenosis Evidence of stent restenosis of the patients receiving primary PCI, confirmed by coronary angiography when patients are readmitted due to the related symptoms. one year after primary PCI
Primary recurrence of myocardial infarction Evidence of myocardial infarction of the patients receiving primary PCI, confirmed by coronary angiography or ECG when patients are readmitted due to the related symptoms. one year after primary PCI
Primary heart failure Evidence of heart failure of the patients receiving primary PCI, confirmed by clinical diagnosis when patients are readmitted due to the related symptoms. one year after primary PCI
Primary cardiac death Evidence of death due to the cardiac dysfunction of the patients receiving primary PCI. one year after primary PCI
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