Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS

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

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-30

Study Completion Date

2024-08-28

Brief Summary

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Acute heart failure (HF) is a common complication of acute coronary syndrome (ACS) associated with poor prognosis. Diagnosis of congestive HF in patients with initial, non-severe symptoms and signs may be challenging and early stages of this complication may be missed. To assess severity of HF in patients with ACS Killip classification is widely used but it does not take into account mild manifestations of HF. Thus, patients without rales in the lungs and/or S3 will be labelled as Killip class 1. The aim of this study is to determine the frequency, risk factors, abilities for early diagnosis using routine medical evaluation and clinical significance of subclinical and mildly symptomatic congestive HF in patients with ACS without persistent ST-segment elevation (NSTEACS).

The study will include 200 patients with NSTEACS without history of severe HF and overt signs of congestion at presentation. Presence and severity of dyspnea (according to Likert ans Visual analog scales), physical signs of heart failure (respiratory rate, distention of jugular veins, S3), peripheral oxygen saturation by pulse oximetry, heart rate and signs of ischemia on ECG, signs of congestion according to lung and vena cava inferior ultrasound and chest X-Ray/CT as well as levels of NT-proBNP, hsTn, CRP and FABP at presentation will be evaluated. Presence and severity of dyspnea, physical signs of heart failure, oxygen saturation, heart rate and signs of ischemia on ECG, lung and vena cava inferior ultrasound will be re-assessed after 6, 12 and 24 hours. During hospitalization occurrence or worsening of clinical HF. Clinical events will be followed up to 12 months after hospitalization.

Detailed Description

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Conditions

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Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome

Keywords

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acute heart failure, congestive heart failure, non-ST-segment elevation acute coronary syndrome, lung ultrasound, vena cava inferior ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalized to the cardiac intensive care unit with ACS without persistent ST-segment elevation
* Signed informed consent

Exclusion Criteria

* ACS with persistent ST-segment elevation
* High probability of absence of ACS
* Congestive rales in the base of lungs, cardiac asthma, pulmonary edema, cardiogenic shock, obvious edema, anasarca
* History of severe chronic heart failure (III-IV NYHA class, obvious edema, anasarca)
* Continuous use of loop diuretics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Health of the Russian Federation and City clinical hospital named after A. K. Eramishantsev, Moscow, Russia, 129327

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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7

Identifier Type: -

Identifier Source: org_study_id