Clinical trial NCT04739098: Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS
Official title: Initial Manifestations of Congestive Heart Failure in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome
Keywords: acute heart failure, congestive heart failure, non-ST-segment elevation acute coronary syndrome, lung ultrasound, vena cava inferior ultrasound
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Moscow City Hospital named after A.K. Eramishantsev
First posted: 2021-02-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ACS without persistent ST-segment elevation without history of severe HF and clinical signs of congestion at presentation

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Worsening of HF from enrollment to 24 hours
timeFrame: from enrollment up to 24 hours
Secondary outcomes:
measure: Changes severity of congestion according to lung and vena cava inferior ultrasound from enrollment to 24 hours after initial assessment at presentation
timeFrame: from enrollment up to 24 hours
measure: Composite of death, (re)myocardial infarction, stroke or hospitalisation for 12 months
timeFrame: up to 12 months
measure: Composite of death, (re)infarction, stroke or worsening of HF from enrollment to discharge from the hospital
timeFrame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
References: