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

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).

Study Overview

• Status: Completed
• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Approaches to differential diagnosis and risk stratification

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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Eramishantsev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients delivered by ambulance and admitted to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected NSTEACS; Patients urgently admitted to the CCU with suspected NSTEACS	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.

What is the study measuring?

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.

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Investigators: Principal Investigator: Igor S Yavelov, PhD, National Medical Research Center for Therapy and Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Prognosis; Diagnosis; Non ST segment Elevation Acute Coronary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 01-02/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No