Systolic Time Intervals in the Diagnosis of Heart Failure in Emergency Departement

Dyspnea Clinical Trial

— STA/AHF  

Official title:

Systolic Time Intervals: a Diagnostic Tool of Acute Heart Failure in Emergency Departement Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161445
• Other study ID #: STI in AHF
• Status: Completed
• Start date: October 2, 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non traumatic dyspnea

• age more than 18 years old.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dyspnea
• Emergencies
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Nouira Semir	Monastir	Emergency Department Monastir, Tunisia 5000

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at admission (an average of 24 hours)
Secondary	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.	at admission (an average of 24 hours)
Secondary	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.	at admission (an average of 24 hours)
Secondary	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	at hospital admission (an average of 24 hours)

External Links

•   official department website