Skip to main content
OpenTrials
Completed

NCT Number: NCT03831204

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Monastir, 5000, Tunisia

About this study

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.

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
  • 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

BIOPAC

Device

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.

prognostic scores

Diagnostic Test

Effect and GWTGHF were calculated for every patient

Primary outcomes

  1. compare the STIs prognostic performance against clinical scores

    Time frame: 30 days

    the area under ROC curve of the Systolic Time Intervals compared to the one of the EFFECT and GWTG HF scores

Secondary outcomes

  1. compare the STI prognostic performance between HFpEF and HFrEF patients

    Time frame: 30 days

    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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.