Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS

NCT04400500 | Completed DMC

• 1 other identifier: 01-02/20
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Non ST segment Elevation Acute Coronary Syndrome; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Death

  6 months.

• (re) infarction

  Up to 1 monts

• Stroke

  6 months.

• Re-hospitalization

  6 months.

Other Outcomes (2)

• Urgent revascularisation

  Up to 1 monts

• Other adverse events

  6 months.

Study Arms (1)

Suspected NSTEACS

Patients urgently admitted to the CCU with suspected NSTEACS

Diagnostic Test: Approaches to differential diagnosis and risk stratification

Interventions

Approaches to differential diagnosis and risk stratification 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.

Suspected NSTEACS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Delivered by ambulance to the CCU with suspected diagnosis "acute coronary syndrome (ACS)".
• Signed informed consent.

You may not qualify if:

• ACS with persistent ST-segment elevation.
• Moribund; extremely severe condition on admission with a potentially unfavourable prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical ventilation).
• Overt non-cardiac cause of clinical manifestations at the time of admission (bleeding, pulmonary embolism, aortic dissection, stroke).

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

Study Sites (1)

Eramishantsev Hospital

Moscow, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

hsTn, NT-proBNP, hsCPR, cardiac FABP

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor S Yavelov, PhD

  National Medical Research Center for Therapy and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 22, 2020
• Study Start: March 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)