Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non ST Segment Elevation Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Approaches to differential diagnosis and risk stratification


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected NSTEACS<br>Patients urgently admitted to the CCU with suspected NSTEACS | Diagnostic Test: Approaches to differential diagnosis and risk stratification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non ST segment Elevation Acute Coronary Syndrome, Diagnosis, Prognosis