Acute Heart Failure, Non-ST-segment Elevation Acute Coronary SyndromeNCT04739098
Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS
An observational study of Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jan 2020to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ACS without persistent ST-segment elevation without history of severe HF and clinical signs of congestion at presentation
Who may be able to join
- Patients hospitalized to the cardiac intensive care unit with ACS without persistent ST-segment elevation
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
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, 101990
About this study
Official title: Initial Manifestations of Congestive Heart Failure in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
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.
- Keywords
- acute heart failure, congestive heart failure, non-ST-segment elevation acute coronary syndrome, lung ultrasound, vena cava inferior ultrasound
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment up to 24 hours
Secondary outcomes (3)
Changes severity of congestion according to lung and vena cava inferior ultrasound from enrollment to 24 hours after initial assessment at presentation
Measured: from enrollment up to 24 hours
Composite of death, (re)myocardial infarction, stroke or hospitalisation for 12 months
Measured: up to 12 months
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.
Measured: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start30 Jan 2020
- Primary completion2 May 2023
- Study completion28 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure, Non-ST-segment Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Moscow City Hospital named after A.K. Eramishantsev
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739098
- Sponsor's protocol ID
- 7
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Manifestations of Congestive Heart Failure in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04739098
- Acronym / sponsor ID
- 7
- Keywords
- acute heart failure, congestive heart failure, non-ST-segment elevation acute coronary syndrome, lung ultrasound, vena cava inferior ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- Moscow City Hospital named after A.K. Eramishantsev
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 28 Aug 2024 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACS without persistent ST-segment elevation without history of severe HF and clinical signs of congestion at presentation
Key inclusion criteria (2 listed)
- Patients hospitalized to the cardiac intensive care unit with ACS without persistent ST-segment elevation
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Worsening of HF from enrollment to 24 hours
Time frame: from enrollment up to 24 hours
Worsening of HF is stated if at least one of following is present 1. ≥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. 2. 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). 3. Appearance of S3 gallop. 4. Appearance of congestive rales in the lungs. 5. Appearance of peripheral oedema related to HF. 6. Intravenous administration of diuretics/vasodilators due to clinical deterioration of HF.
3 secondary outcomes
Changes severity of congestion according to lung and vena cava inferior ultrasound from enrollment to 24 hours after initial assessment at presentation
Time frame: from enrollment up to 24 hours
Composite of death, (re)myocardial infarction, stroke or hospitalisation for 12 months
Time frame: up to 12 months
Composite of death, (re)infarction, stroke or worsening of HF from enrollment to discharge from the hospital
Time frame: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome
Active, not recruitingPhase 3
Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus
Intracardiac Thrombus, STEMI
RecruitingObservational study
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of HF from enrollment to 24 hours (time frame: from enrollment up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.