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Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

NCT ID: NCT04400500

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Non ST Segment Elevation Acute Coronary Syndrome

Keywords

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Non ST segment Elevation Acute Coronary Syndrome Diagnosis Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected NSTEACS

Patients urgently admitted to the CCU with suspected NSTEACS

Approaches to differential diagnosis and risk stratification

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor S Yavelov, PhD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Therapy and Preventive Medicine

Locations

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Eramishantsev Hospital

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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01-02/20

Identifier Type: -

Identifier Source: org_study_id