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

NCT02161445 | Completed DMC

• 1 other identifier: STI in AHF
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspnea

Keywords

impedance; pep; tevg; dyspnea; AHF; BNP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PEP values between the two study groups

  at admission (an average of 24 hours)

• compare the EMAT values between the two study groups

  at admission (an average of 24 hours)

• compare the STI diagnostic performance against BNP

  at hospital admission (an average of 24 hours)

Study Arms (2)

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).

Device: the acoustic cardiographic parameters were calculated

non AHF group

we included patients with acute dyspnea and for whom acute heart failure was excluded

Device: the acoustic cardiographic parameters were calculated

Interventions

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.

AHF group; non AHF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged more than 18 years old presenting at the ED with non traumatic dyspnea.

You may qualify if:

• non traumatic dyspnea
• age more than 18 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Nouira Semir

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

Location

Related Links

• official department website

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Nouira Samir, Professor

  University hospital of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: June 11, 2014
• Study Start: October 2, 2012
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)