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Clinical Trials/NCT04400500
NCT04400500
Completed
Not Applicable

Approaches to Differential Diagnosis and Risk Stratification in Patients Hospitalized With Suspected Acute Coronary Syndrome Without Persistent ST-segment Elevation

National Research Center for Preventive Medicine1 site in 1 country140 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non ST Segment Elevation Acute Coronary Syndrome
Sponsor
National Research Center for Preventive Medicine
Enrollment
140
Locations
1
Primary Endpoint
Clinical outcomes
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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).

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Research Center for Preventive Medicine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Delivered by ambulance to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".
  • Signed informed consent.

Exclusion Criteria

  • ACS with persistent ST-segment elevation.
  • Moribund; extremely severe condition on admission with a potentially unfavourable prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical ventilation).
  • Overt non-cardiac cause of clinical manifestations at the time of admission (bleeding, pulmonary embolism, aortic dissection, stroke).

Outcomes

Primary Outcomes

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 Outcomes

  • Death(6 months.)
  • (re) infarction(Up to 1 monts)
  • Stroke(6 months.)
  • Re-hospitalization(6 months.)

Study Sites (1)

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