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Completed

NCT Number: NCT02161445

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

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.

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Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nouira Semir

Monastir, Emergency Department Monastir, Tunisia 5000, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the acoustic cardiographic parameters were calculated

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. PEP values between the two study groups

    Time frame: at admission (an average of 24 hours)

    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.

  2. compare the EMAT values between the two study groups

    Time frame: at admission (an average of 24 hours)

    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.

  3. compare the STI diagnostic performance against BNP

    Time frame: at hospital admission (an average of 24 hours)

    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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: STA/AHF

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Jun 11, 2014
Registry last updated
Jul 1, 2020

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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