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

Overview

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.

Full Title of Study: “Using Soluble ST2 to Predict Clinical Outcomes in Patients Receiving Primary Percutaneous Coronary Intervention With ST-elevation Myocardial Infarction”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2018

Arms, Groups and Cohorts

  • STEMI patients having primary PCI
    • Patients with STEMI receiving primary PCI in Wuhan Aisa Heart Hospital are included in this study. All patients are the first time to have STEMI, and primary PCIs are performed according to 2013 ACCF/AHA guideline for the management of STEMI. Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases are excluded from this study.

Clinical Trial Outcome Measures

Primary Measures

  • stent restenosis
    • Time Frame: one year after primary PCI
    • Evidence of stent restenosis of the patients receiving primary PCI, confirmed by coronary angiography when patients are readmitted due to the related symptoms.
  • recurrence of myocardial infarction
    • Time Frame: one year after primary PCI
    • 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.
  • heart failure
    • Time Frame: one year after primary PCI
    • Evidence of heart failure of the patients receiving primary PCI, confirmed by clinical diagnosis when patients are readmitted due to the related symptoms.
  • cardiac death
    • Time Frame: one year after primary PCI
    • Evidence of death due to the cardiac dysfunction of the patients receiving primary PCI.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wuhan Asia Heart Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xuan Zheng, vice director of laboratory of molecular cardiology – Wuhan Asia Heart Hospital
  • Overall Official(s)
    • Xuan Zheng, MD,PhD, Principal Investigator, Wuhan Asia Heart Hospital

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