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

• ClinicalTrials.gov Identifier: NCT03831204
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: July 20, 2020
• Sponsor: University of Monastir
• Information provided by (Responsible Party): Pr. Semir Nouira, University of Monastir

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Dyspnea; Heart Failure	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 Design

• Study Type: Observational
• Actual Enrollment: 642 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Systolic Time Intervals a Pronostic Tool of Heart Failure in Emergency Departement
• Actual Study Start Date: February 20, 2017
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: June 30, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

Criteria

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

Contacts and Locations

Locations

Tunisia

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

Monastir, Tunisia, 5000

Sponsors and Collaborators

University of Monastir

Investigators

• Principal Investigator: Nouira Semir, Pr; University hospital of Monastir

More Information

Additional Information:

official department website 

• Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT03831204
• Other Study ID Numbers: STI in AHF prognostic
• First Posted: February 5, 2019
• Last Update Posted: July 20, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pr. Semir Nouira, University of Monastir:

impedance; dyspnea; AHF; BNP; EFFECT; GWTG-HF

Additional relevant MeSH terms:

Dyspnea; Heart Failure; Emergencies; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory