DyspneaNCT03831204
Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)
An observational study of Dyspnea and Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial summary
The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Heart Failure
- What is being tested?
- biopac and prognostic scores
- Type of treatment
- Medical device
- How many people
- 642 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Feb 2017to 30 Jun 2019
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients aged more than 18 years admitted to the ED with the diagnosis of acute decompensated heart failure
Who may be able to join
- non traumatic dyspnea
- age more than 18 years old.
Who cannot join
- ECG diagnostic for acute myocardial infarction
- ischemic chest pain within the prior 24 hours
- history of a heart transplant
- pericardial effusion
- chest wall deformity suspected of causing dyspnea
- coma
Show all 12Show fewer
- shock,Mechanical Ventilation, vasopressor drugs
- arrhythmia serious and sustained,
- pace maker
- severe mitral valve disease,
- severe pulmonary arterial hypertension
- renal failure with creatinine >350micromol/l
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Monastir, 5000
About this study
Official title: Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement
The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.
Read the detailed description
Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.
STI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:
pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.
The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.
- Conditions
- Dyspnea, Heart Failure
- Being tested
- biopac, prognostic scores
- Keywords
- impedance, dyspnea, AHF, BNP, EFFECT, GWTG-HF
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopacDevice
Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.
prognostic scoresDiagnostic test
Effect and GWTGHF were calculated for every patient
| Study group | Role | What they receive |
|---|---|---|
| AHF/HFpEF | AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient Receives: Device: biopac; Diagnostic Test: prognostic scores | |
| AHF/HFrEF | AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient Receives: Device: biopac; Diagnostic Test: prognostic scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the STIs prognostic performance against clinical scores
the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores
Measured: 30 days
Secondary outcomes (1)
compare the STI prognostic performance between HFpEF and HFrEF patients
compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start20 Feb 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Pr, Principal investigator, University hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831204
- Sponsor's protocol ID
- STI in AHF prognostic
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2018
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement
- ClinicalTrials.gov ID
- NCT03831204
- Acronym / sponsor ID
- STI in AHF prognostic
- Conditions
- Dyspnea, Heart Failure
- Keywords
- impedance, dyspnea, AHF, BNP, EFFECT, GWTG-HF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Feb 2019 (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.
The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.
Detailed description
Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.
STI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:
pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.
The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHF/HFpEF | – | Device: biopac, Diagnostic Test: prognostic scoresAHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient |
| AHF/HFrEF | – | Device: biopac, Diagnostic Test: prognostic scoresAHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients aged more than 18 years admitted to the ED with the diagnosis of acute decompensated heart failure
Key inclusion criteria (2 listed)
- non traumatic dyspnea
- age more than 18 years old.
Key exclusion criteria (12 listed)
- ECG diagnostic for acute myocardial infarction
- ischemic chest pain within the prior 24 hours
- history of a heart transplant
- pericardial effusion
- chest wall deformity suspected of causing dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopacAcoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus. | Device | AHF/HFpEF, AHF/HFrEF |
| prognostic scoresEffect and GWTGHF were calculated for every patient | Diagnostic test | AHF/HFpEF, AHF/HFrEF |
Primary outcome
compare the STIs prognostic performance against clinical scores
Time frame: 30 days
the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores
1 secondary outcome
compare the STI prognostic performance between HFpEF and HFrEF patients
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- official department websiteLink provided by the sponsor.
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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.
Nouira Semir, Pr principal investigator
University hospital of Monastir
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 Dyspnea and Heart Failure, run by University of Monastir at 1 site in Tunisia.
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 12 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: finished, as of the sponsor's last update on 20 Jul 2020. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
compare the STIs prognostic performance against clinical scores (time frame: 30 days). 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 20 Jul 2020.