Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400500
• Other study ID #: 01-02/20
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Approaches 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.

Locations

Country	Name	City	State
Russian Federation	Eramishantsev Hospital	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urgent revascularisation	Revascularisation performed due to sudden clinical deterioration	Up to 1 monts
Other	Other adverse events	All adverse events/complications not included in clinical outcomes end points.	6 months.
Primary	Clinical outcomes	Composite of death, (re) infarction, stroke or re-hospitalization	6 monts
Primary	Final diagnosis	Final diagnosis - the main reason for urgent hospitalization - according to hospital case history	Up to 1 monts
Secondary	Death	Death upon discharge and up to 6 months	6 months.
Secondary	(re) infarction	(re) infarction upon discharge and up to 6 months	Up to 1 monts
Secondary	Stroke	Stroke upon discharge and up to 6 months	6 months.
Secondary	Re-hospitalization	Recurrent hospital admissions after discharge form the index hospitalization	6 months.