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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831204
• Other study ID #: STI in AHF prognostic
• Status: Completed
• Start date: February 20, 2017
• Est. completion date: June 30, 2019

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Emergencies
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Tunisia	Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   official department website