An observational study in Dyspnea, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by University of Monastir · Observational
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.
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:
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:
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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 530 is above the median of 122 across 204 observational studies indexed under Dyspnea.
Browse Dyspnea studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients aged more than 18 years old presenting at the ED with non traumatic dyspnea.
Exclusion Criteria:
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).
Device: the acoustic cardiographic parameters were calculated
we included patients with acute dyspnea and for whom acute heart failure was excluded
Device: the acoustic cardiographic parameters were calculated
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.
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.
Time frame: at admission (an average of 24 hours)
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.
Time frame: 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.
Time frame: 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
Time frame: at hospital admission (an average of 24 hours)
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Monastir