Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04739098
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2021-02-01
Brief Title:
Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS
Sponsor:
National Medical Research Center for Therapy and Preventive Medicine
Organization:
National Medical Research Center for Therapy and Preventive Medicine
Study Overview
Official Title:
Initial Manifestations of Congestive Heart Failure in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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-RayCT 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
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-RayCT 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None