Clinical trial NCT04400500: Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS
Official title: Approaches to Differential Diagnosis and Risk Stratification in Patients Hospitalized With Suspected Acute Coronary Syndrome Without Persistent ST-segment Elevation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Keywords: Non ST segment Elevation Acute Coronary Syndrome
Diagnosis
Prognosis
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2020-05-22
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients delivered by ambulance and admitted to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Clinical outcomes
timeFrame: 6 monts
measure: Final diagnosis
timeFrame: Up to 1 monts
Secondary outcomes:
measure: Death
timeFrame: 6 months.
measure: (re) infarction
timeFrame: Up to 1 monts
measure: Stroke
timeFrame: 6 months.
measure: Re-hospitalization
timeFrame: 6 months.
Other outcomes:
measure: Urgent revascularisation
timeFrame: Up to 1 monts
measure: Other adverse events
timeFrame: 6 months.
Locations:
city: Moscow
country: Russian Federation
facility: Eramishantsev Hospital
Study officials:
affiliation: National Medical Research Center for Therapy and Preventive Medicine
name: Igor S Yavelov, PhD
role: PRINCIPAL_INVESTIGATOR
References: