Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

Overview

To evaluate possibilities of rapid differential diagnosis and risk stratification in patients urgently admitted to the CCU with a suspected acute coronary syndrome without persistent ST-segment elevation (NSTEACS).

Full Title of Study: “Approaches to Differential Diagnosis and Risk Stratification in Patients Hospitalized With Suspected Acute Coronary Syndrome Without Persistent ST-segment Elevation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2022

Detailed Description

Single centre prospective non-randomised non-comparative study of patients delivered by ambulance and admitted to the CCU with suspected NSTEACS.

Aims of this study are:

1. To characterize the contingent of patients admitted to the CCU with suspected NSTEACS.

2. To evaluate possibilities of fast differential diagnosis and risk stratification in patients admitted to the CCU with suspected NSTEACS using clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.

3. To evaluate the correlation between clinical data, ECG, biomarker levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores with presence and severity of coronary atherosclerosis in patients admitted to the CCU (intensive care unit) with suspected NSTEACS.

Interventions

  • Diagnostic Test: Approaches to differential diagnosis and risk stratification
    • Detailed analysis of clinical course, ECG, biomarkers (hsTn I, CK-MB mass, myoglobin, NT-proBNP, hsCPR, cardiac FABP on admission and after 3 hours; hsTn I, CK-MB mass and myoglobin after 6 hours if needed) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.

Arms, Groups and Cohorts

  • Suspected NSTEACS
    • Patients urgently admitted to the CCU with suspected NSTEACS

Clinical Trial Outcome Measures

Primary Measures

  • Clinical outcomes
    • Time Frame: 6 monts
    • Composite of death, (re) infarction, stroke or re-hospitalization
  • Final diagnosis
    • Time Frame: Up to 1 monts
    • Final diagnosis – the main reason for urgent hospitalization – according to hospital case history

Secondary Measures

  • Death
    • Time Frame: 6 months.
    • Death upon discharge and up to 6 months
  • (re) infarction
    • Time Frame: Up to 1 monts
    • (re) infarction upon discharge and up to 6 months
  • Stroke
    • Time Frame: 6 months.
    • Stroke upon discharge and up to 6 months
  • Re-hospitalization
    • Time Frame: 6 months.
    • Recurrent hospital admissions after discharge form the index hospitalization

Participating in This Clinical Trial

Inclusion Criteria

1. Delivered by ambulance to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".

2. Signed informed consent.

Exclusion Criteria

1. ACS with persistent ST-segment elevation.

2. Moribund; extremely severe condition on admission with a potentially unfavourable prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical ventilation).

3. Overt non-cardiac cause of clinical manifestations at the time of admission (bleeding, pulmonary embolism, aortic dissection, stroke).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Research Center for Preventive Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Igor S Yavelov, PhD, Principal Investigator, National Medical Research Center for Therapy and Preventive Medicine
  • Overall Contact(s)
    • Vitaliy A Moshanov, RA, 79175694724, moshanov.vitalii@mail.ru

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