DyspneaSTA/AHFNCT02161445
Systolic Time Intervals in the Diagnosis of Heart Failure in Emergency Departement
An observational study of Dyspnea, run by University of Monastir at 1 site in Tunisia.
Trial summary
the gold standard for the diagnostic of acute heart failure is based on clinical, biological (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyspnea
- What is being tested?
- the acoustic cardiographic parameters were calculated
- Type of treatment
- Medical device
- How many people
- 530 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Oct 2012to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged more than 18 years old presenting at the ED with non traumatic dyspnea.
Who may be able to join
- non traumatic dyspnea
- age more than 18 years old.
Who cannot join
- ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours
- history of a heart transplant
- pericardial effusion
- chest wall deformity suspected of causing dyspnea
- coma, 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
Nouira Semir
Monastir, Emergency Department Monastir, Tunisia 5000, 5000
About this study
Official title: Systolic Time Intervals: a Diagnostic Tool of Acute Heart Failure in Emergency Departement Settings
the gold standard for the diagnostic of acute heart failure is based on clinical, biological (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations.
BNP dosages and echocardiography are not always available in many medical centers, especially in emergency departements, and are expensive.
we investigated the use of alternative methods, such as the systolic time intervals (STI), in the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for dyspnea.
Read the detailed description
AHF is a common cause for dyspnea, but still hard to diagnose. in emergency departements, physicians dispose of a variety of techniques helping them to identify patients with acute onset dyspnea due to cardiac causes and allowing them to initiate the appropriate therapeutics.
techniques such as the N type brain natriuretic peptid (NT BNP) dosages and echocardiography, in addition to the clinical exam, are efficient in these cases but they encounter many problems:
- the BNP dosages are non-conclusive in some cases (grey zone) and must be repeated wich takes time.
- echocardiography is operator - dependent technique and could be misleading in some conditions.
- both BNP and echocardiography are expensive and not found in many emergency structures, especially in poor countries. all the arguments pushed us to investigate other simpler and cheaper techniques to apply in these conditions.
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): defined as the interval between the beginning of the QRS wave and the first heart sound (B1).
- electro-mechanic activation time (EMAT): defined as the interval between the two heart sounds B1 and B2
- the PEP / EMAT time in acute onset heart failure, the conduction times are increased, due to tissular lesions, which prolong the PEP, also the myocardial contractility is deficient and the heart puts less time to eject the blood volume which decrease the EMAT and in summary the PEP/EMAT is increased significatively. in this study protocol, we aimed to investigate the diagnostic performance of STI compared to conventional methods in the diagnosis of acute heart failure in emergency department settings.
- Conditions
- Dyspnea
- Being tested
- the acoustic cardiographic parameters were calculated
- Keywords
- impedance, pep, tevg, dyspnea, AHF, BNP
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the acoustic cardiographic parameters were calculatedDevice
STIs were measured using simultaneous recording of the electrocardiogram and acoustic cardiography signals using an analogic numeric system (Biopac Systems, Goleta, CA). A3-minute acoustic cardiographic tracing for all patients was obtained and stored electronically. We measured the electromechanical activation time (EMAT) which is the time between the initial deflection of the electrocardiographic Q wave and the first phonocardiographic complex corresponding to the first heart sound (S1). The left ventricle ejection time (LVET) defined as the interval between the peak components from the S1 and S2 complexes was measured on the same cardiac cycles. All studies were performed in patients in a semi-recumbent position with head at 30 degrees position. For each patient, the acoustic cardiographic parameters were calculated from a 10-second free of artifact recording of data averaging 8 to 12 beats measurements.
| Study group | Role | What they receive |
|---|---|---|
| AHF group | patients with AHF diagnosed based on clinical, biological and echocardiographic findings. Two sub-groups of patients were identified within HF group: Patients with reduced (<45%) LVEF (HFrEF) and those with preserved (≥45%) LVEF (HFpEF). Receives: Device: the acoustic cardiographic parameters were calculated | |
| non AHF group | we included patients with acute dyspnea and for whom acute heart failure was excluded Receives: Device: the acoustic cardiographic parameters were calculated |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEP/EMAT values between the AHF and non AHF groups
compare the PEP/EMAT values between the two study groups: AHF and non-AHF. the diagnosis of AHF is made based on clinical, BNP, and echocardiographic findings.
Measured: at admission (an average of 24 hours)
Secondary outcomes (3)
PEP values between the two study groups
compare the PEP values between the two study groups: AHF and non-AHF. the diagnosis of AHF is made based on clinical, BNP, and echocardiographic findings.
Measured: at admission (an average of 24 hours)
compare the EMAT values between the two study groups
compare the EMAT values between the two study groups: AHF and non-AHF. the diagnosis of AHF is made based on clinical, BNP, and echocardiographic findings.
Measured: at admission (an average of 24 hours)
compare the STI diagnostic performance against BNP
compare the diagnostic performance, based on the area under curve estimation of the ROC curve, between the STI (PEP, EMAT and PEP/EMAT) and the BNP levels
Measured: at hospital admission (an average of 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start2 Oct 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 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
- 530 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 Samir, Professor, Principal investigator, University hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161445
- Sponsor's protocol ID
- STI in AHF
- Acronym
- STA/AHF
- Status last verified
- Jun 2020
- First submitted
- 4 May 2014
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systolic Time Intervals: a Diagnostic Tool of Acute Heart Failure in Emergency Departement Settings
- ClinicalTrials.gov ID
- NCT02161445
- Acronym / sponsor ID
- STA/AHF / STI in AHF
- Conditions
- Dyspnea
- Keywords
- impedance, pep, tevg, dyspnea, AHF, BNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 2 Oct 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jun 2014 (estimated)
- 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 gold standard for the diagnostic of acute heart failure is based on clinical, biological (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations.
BNP dosages and echocardiography are not always available in many medical centers, especially in emergency departements, and are expensive.
we investigated the use of alternative methods, such as the systolic time intervals (STI), in the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for dyspnea.
Detailed description
AHF is a common cause for dyspnea, but still hard to diagnose. in emergency departements, physicians dispose of a variety of techniques helping them to identify patients with acute onset dyspnea due to cardiac causes and allowing them to initiate the appropriate therapeutics.
techniques such as the N type brain natriuretic peptid (NT BNP) dosages and echocardiography, in addition to the clinical exam, are efficient in these cases but they encounter many problems:
- the BNP dosages are non-conclusive in some cases (grey zone) and must be repeated wich takes time.
- echocardiography is operator - dependent technique and could be misleading in some conditions.
- both BNP and echocardiography are expensive and not found in many emergency structures, especially in poor countries. all the arguments pushed us to investigate other simpler and cheaper techniques to apply in these conditions.
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): defined as the interval between the beginning of the QRS wave and the first heart sound (B1).
- electro-mechanic activation time (EMAT): defined as the interval between the two heart sounds B1 and B2
- the PEP / EMAT time in acute onset heart failure, the conduction times are increased, due to tissular lesions, which prolong the PEP, also the myocardial contractility is deficient and the heart puts less time to eject the blood volume which decrease the EMAT and in summary the PEP/EMAT is increased significatively. in this study protocol, we aimed to investigate the diagnostic performance of STI compared to conventional methods in the diagnosis of acute heart failure in emergency department settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHF group | – | Device: the acoustic cardiographic parameters were calculatedpatients with AHF diagnosed based on clinical, biological and echocardiographic findings. Two sub-groups of patients were identified within HF group: Patients with reduced (<45%) LVEF (HFrEF) and those with preserved (≥45%) LVEF (HFpEF). |
| non AHF group | – | Device: the acoustic cardiographic parameters were calculatedwe included patients with acute dyspnea and for whom acute heart failure was excluded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged more than 18 years old presenting at the ED with non traumatic dyspnea.
Key inclusion criteria (2 listed)
- non traumatic dyspnea
- age more than 18 years old.
Key exclusion criteria (7 listed)
- ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours
- history of a heart transplant
- pericardial effusion
- chest wall deformity suspected of causing dyspnea
- coma, shock,Mechanical Ventilation, vasopressor drugs
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 |
|---|---|---|
| the acoustic cardiographic parameters were calculatedSTIs were measured using simultaneous recording of the electrocardiogram and acoustic cardiography signals using an analogic numeric system (Biopac Systems, Goleta, CA). A3-minute acoustic cardiographic tracing for all patients was obtained and stored electronically. We measured the electromechanical activation time (EMAT) which is the time between the initial deflection of the electrocardiographic Q wave and the first phonocardiographic complex corresponding to the first heart sound (S1). The left ventricle ejection time (LVET) defined as the interval between the peak components from the S1 and S2 complexes was measured on the same cardiac cycles. All studies were performed in patients in a semi-recumbent position with head at 30 degrees position. For each patient, the acoustic cardiographic parameters were calculated from a 10-second free of artifact recording of data averaging 8 to 12 beats measurements. | Device | AHF group, non AHF group |
Primary outcome
PEP/EMAT values between the AHF and non AHF groups
Time frame: at admission (an average of 24 hours)
compare the PEP/EMAT values between the two study groups: AHF and non-AHF. the diagnosis of AHF is made based on clinical, BNP, and echocardiographic findings.
3 secondary outcomes
PEP values between the two study groups
Time frame: at admission (an average of 24 hours)
compare the EMAT values between the two study groups
Time frame: at admission (an average of 24 hours)
compare the STI diagnostic performance against BNP
Time frame: at hospital admission (an average of 24 hours)
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 1 Jul 2020.
- official department websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Samir, Professor 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, 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 7 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 1 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?
PEP/EMAT values between the AHF and non AHF groups (time frame: at admission (an average of 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 Jul 2020.