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Completed

NCT Number: NCT04400500

Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

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).

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Key information

Conditions

Non ST Segment Elevation Acute Coronary Syndrome Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Eramishantsev Hospital

Moscow, Russia

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Approaches to differential diagnosis and risk stratification

Diagnostic Test

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.

Primary outcomes

  1. Clinical outcomes

    Time frame: 6 monts

    Composite of death, (re) infarction, stroke or re-hospitalization

  2. Final diagnosis

    Time frame: Up to 1 monts

    Final diagnosis - the main reason for urgent hospitalization - according to hospital case history

Secondary outcomes

  1. Death

    Time frame: 6 months.

    Death upon discharge and up to 6 months

  2. (re) infarction

    Time frame: Up to 1 monts

    (re) infarction upon discharge and up to 6 months

  3. Stroke

    Time frame: 6 months.

    Stroke upon discharge and up to 6 months

  4. Re-hospitalization

    Time frame: 6 months.

    Recurrent hospital admissions after discharge form the index hospitalization

Other outcomes

  1. Urgent revascularisation

    Time frame: Up to 1 monts

    Revascularisation performed due to sudden clinical deterioration

  2. Other adverse events

    Time frame: 6 months.

    All adverse events/complications not included in clinical outcomes end points.

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 22, 2020
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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