Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04400500

Enrollment

140

Registered

2020-05-22

Start date

2020-03-01

Completion date

2023-11-30

Last updated

2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Non ST segment Elevation Acute Coronary Syndrome, Diagnosis, Prognosis

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.

Interventions

DIAGNOSTIC_TESTApproaches 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Urgent revascularisation	Up to 1 monts	Revascularisation performed due to sudden clinical deterioration
Other adverse events	6 months.	All adverse events/complications not included in clinical outcomes end points.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026