Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)

Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement

The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Dyspnea
• Intervention / Treatment: Device: biopac; Diagnostic test: prognostic scores

Detailed Description

Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.

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),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.

The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.

• Study Type: Observational
• Enrollment (Actual): 642

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients aged more than 18 years admitted to the ED with the diagnosis of acute decompensated heart failure

Description

Inclusion Criteria:

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

Exclusion Criteria:

• ECG diagnostic for acute myocardial infarction
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AHF/HFpEF; AHF with preserved ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient	Device: biopac; Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.; Diagnostic test: prognostic scores; Effect and GWTGHF were calculated for every patient
AHF/HFrEF; AHF with reduced ejection fraction Acoustic cardiography was performed for all participants using the BIOPAC Prognostic scores were calculated for every patient	Device: biopac; Acoustic cardiography was performed for all participants using the BIOPAC system with "Student Lab" software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus.; Diagnostic test: prognostic scores; Effect and GWTGHF were calculated for every patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the STIs prognostic performance against clinical scores	the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the STI prognostic performance between HFpEF and HFrEF patients	compare the STI prognostic performance between HFpEF and HFrEF patients using the area under curve estimation of the ROC curve of the three systolic time intervals (PEP;EMAT measured in milliseconds,and PEP/EMAT) of the two groups	30 days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira Semir, Pr, University Hospital of Monastir

Publications and helpful links

Helpful Links

• official department website

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: February 2, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: dyspnea; BNP; impedance; AHF; EFFECT; GWTG-HF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Heart Failure; Emergencies; Dyspnea
• Other Study ID Numbers: STI in AHF prognostic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No