Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department

NCT ID: NCT04240067

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2022-12-31

Brief Summary

Elderly people constitute the largest proportion of emergency department (ED) patients, representing 12% of all ED admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for ED admission, and patients suffering from cardiovascular disease are those whose ED visit lasts longest.

The diagnostic approach in the ED in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.

Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides alone suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.

Some authors have studied other biomarkers showing their performance in the diagnosis of ALSHF. These are biomarkers involved in remodeling and myocardial fibrosis (ST2, Galectin-3) or involved in myocardial injury (High-sensitivity Troponin-I).

Therefore, a combined "multimarker" approach could improve the diagnostic performance of ALSHF.

READ (NCT02531542) is a diagnostic study including patients over the age of 75 admitted to acute dyspnea in the ED, to demonstrate the superiority of an ultrasound protocol (the READ protocol) on NT-proBNP in the ALSHF diagnosis.

The hypothesis is that the diagnostic accuracy of a multimarker diagnostic approach, namely the READ-MA method, combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3 would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the ED.

Conditions

Acute Dyspnea; Acute Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Heart Failure

READ-MA Multimarker Approach

Intervention Type: DIAGNOSTIC_TEST

The presence or absence of ALSHF (gold standard used in the READ study) : diagnosis by 2 experts (cardiologist and emergency physician) based on data collected in the ED and during hospitalization (clinical examination, history, usual treatment, haemodynamic parameters, ECG, chest X-ray, emergency treatment, clinical and paraclinical results during hospitalization), biological assays (except NT-proBNP) and echocardiography (Left Ventricular Ejection Fraction, segmental kinetic, potential valvulopathy, transmitral flow, tissue doppler E' velocity) performed by a cardiologist within 24 hours of admission.

No Acute Heart Failure

READ-MA Multimarker Approach

Intervention Type: DIAGNOSTIC_TEST

The presence or absence of ALSHF (gold standard used in the READ study) : diagnosis by 2 experts (cardiologist and emergency physician) based on data collected in the ED and during hospitalization (clinical examination, history, usual treatment, haemodynamic parameters, ECG, chest X-ray, emergency treatment, clinical and paraclinical results during hospitalization), biological assays (except NT-proBNP) and echocardiography (Left Ventricular Ejection Fraction, segmental kinetic, potential valvulopathy, transmitral flow, tissue doppler E' velocity) performed by a cardiologist within 24 hours of admission.

Interventions

READ-MA Multimarker Approach

The presence or absence of ALSHF (gold standard used in the READ study) : diagnosis by 2 experts (cardiologist and emergency physician) based on data collected in the ED and during hospitalization (clinical examination, history, usual treatment, haemodynamic parameters, ECG, chest X-ray, emergency treatment, clinical and paraclinical results during hospitalization), biological assays (except NT-proBNP) and echocardiography (Left Ventricular Ejection Fraction, segmental kinetic, potential valvulopathy, transmitral flow, tissue doppler E' velocity) performed by a cardiologist within 24 hours of admission.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Admission to the Emergency Department with age ≥ 75 years
• AND criteria of acute dyspnea :

Breathe rate ≥ 25 cycles/minute or PaO2 ≤ 70 mmHg or SpO2 ≤ 92% in room air or PacO2 ≥ 45 mmHg and pH ≤ 7.35

• AND Electrocardiogram in sinus rhythm or in atrial fibrillation at admission

Exclusion Criteria

• none

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric MAUNY, Prof, MD, PhD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Besancon

Noémie NMINEJ

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Besancon

Patrick RAY, Prof, MD, PhD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Dijon

Camille CHENEVIER-GOBEAUX, PharmD, PhD

Role: STUDY_CHAIR

Hôpital Cochin, Assistance Publique Hôpitaux de Paris

Marie-Hélène TOURNOYS, PharmD

Role: STUDY_CHAIR

Centre Hospitalier de Bethune

Marc PUYRAVEAU, MSc

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Besancon

Alain-Eric DUBART, MD

Role: STUDY_CHAIR

CH Béthune

Locations

Centre Hospitalier Universitaire de Besançon

Besançon, Franche-Comté, France

Countries

France

Other Identifiers

P/2019/466

Identifier Type: -

Identifier Source: org_study_id