Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome Clinical Trial
Official title:
Initial Manifestations of Congestive Heart Failure in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
| Verified date | November 2023 |
| Source | National Medical Research Center for Therapy and Preventive Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | August 28, 2024 |
| Est. primary completion date | May 2, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| National Medical Research Center for Therapy and Preventive Medicine | Clinical City Hospital named after A. K. Eramishantsev of Moscow Department of Healthcare |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Worsening of HF from enrollment to 24 hours | Worsening of HF is stated if at least one of following is present
=1 point increase of dyspnea according to 5-point Likert score: 1=not short of breath, 2=mildly short of breath, 3=moderately short of breath, 4=severely short of breath, 5=very severely short of breath. Appearance/increase of jugular vein distension (if starting to be seen in patients lying horizontally or increasing degree of head of bed elevation for its disappearance). Appearance of S3 gallop. Appearance of congestive rales in the lungs. Appearance of peripheral oedema related to HF. Intravenous administration of diuretics/vasodilators due to clinical deterioration of HF. |
from enrollment up to 24 hours | |
| Secondary | Changes severity of congestion according to lung and vena cava inferior ultrasound from enrollment to 24 hours after initial assessment at presentation | from enrollment up to 24 hours | ||
| Secondary | Composite of death, (re)myocardial infarction, stroke or hospitalisation for 12 months | up to 12 months | ||
| Secondary | Composite of death, (re)infarction, stroke or worsening of HF from enrollment to discharge from the hospital | Worsening of HF is stated if at least one of following is present
Appearance of congestive rales in the lungs. Appearance of peripheral oedema related to HF. Intravenous administration of diuretics/vasodilators due to clinical deterioration of HF. |
from admission to discharge or death during reference hospitalization, assessed up to 90 days |