Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

Completed

• Conditions: Non ST Segment Elevation Acute Coronary Syndrome

• Registration Number: NCT04400500
• Lead Sponsor: National Research Center for Preventive Medicine

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Death	6 months.	Death upon discharge and up to 6 months
(re) infarction	Up to 1 monts	(re) infarction 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

Trial Locations

Locations (1)

Eramishantsev Hospital; 🇷🇺 Moscow, Russian Federation