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

NCT04240067 | Completed DMC

• 1 other identifier: P/2019/466
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To assess the diagnostic performance of the multimarker approach (combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3) for the diagnosis of ALSHF in patients aged ≥75 years admitted to the ED for acute dyspnea

  1. 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, biological assays (except NT-proBNP) and echocardiography performed by a cardiologist. 2. The positivity of the evaluated test (multi-marker approach) : * For NT-proBNP, the threshold for positivity is higher than 1800 pg/mL. There is no consensus for High-Sensitivity Troponin-I, ST2 and Galectin-3. Firstly, the optimal threshold of each of these 3 biomarkers will be assessed by ROC curve, then the best combination between these 4 biomarkers will be tested to obtain an optimal discrimination (sensitivity, specificity positive and negative predictive values), positive and negative likelihood ratios) using various methods.

  1 day

Secondary Outcomes (1)

• To demonstrate the superiority of the multimarker approach (NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3) over NT-proBNP alone for the diagnosis of ALSHF in patients aged ≥75 years admitted to the ED for acute dyspnea

  1 day

Study Arms (2)

Acute Heart Failure

Diagnostic Test: READ-MA Multimarker Approach

No Acute Heart Failure

Diagnostic Test: READ-MA Multimarker Approach

Interventions

READ-MA Multimarker Approach 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.

Acute Heart Failure; No Acute Heart Failure

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged ≥75 years admitted to the ED for acute dyspnea

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, Franche-Comté, 25000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Study Officials

• Frédéric MAUNY, Prof, MD, PhD

  Centre Hospitalier Universitaire de Besancon

  STUDY CHAIR

• Noémie NMINEJ

  Centre Hospitalier Universitaire de Besancon

  STUDY CHAIR

• Patrick RAY, Prof, MD, PhD

  Centre Hospitalier Universitaire Dijon

  STUDY CHAIR

• Camille CHENEVIER-GOBEAUX, PharmD, PhD

  Hôpital Cochin, Assistance Publique Hôpitaux de Paris

  STUDY CHAIR

• Marie-Hélène TOURNOYS, PharmD

  Centre Hospitalier de Bethune

  STUDY CHAIR

• Marc PUYRAVEAU, MSc

  Centre Hospitalier Universitaire de Besancon

  STUDY CHAIR

• Alain-Eric DUBART, MD

  CH Béthune

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: September 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2022
• Last Updated: November 18, 2024

Record last verified: 2020-01

Locations

FR (1)