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Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department (READ-MA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240067
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment
Acute Dyspnea Acute Heart Failure Diagnostic Test: READ-MA Multimarker Approach

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute Heart Failure Diagnostic Test: 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.

No Acute Heart Failure Diagnostic Test: 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.




Primary Outcome Measures :
  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 [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  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 [ Time Frame: 1 day ]

    To demonstrate the superiority of this combined multi-marker approach combining NT-proBNP, Troponin-I ultrasensitive, ST-2 and Galectin-3 on NT-proBNP alone in the diagnosis of ALSHF in subjects over 75 years admitted to emergencies for acute dyspnea, will be evaluated :

    • The presence or absence of acute left heart failure (gold standard selected in the context of the READ study) will be determined using the previously defined criteria
    • The evaluated test will be the best multimarker approach previously determined, classified as positive or negative using the previously defined criteria
    • The comparative test (NT-proBNP alone) will be classified positive for a threshold higher than 1800 pg/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients aged ≥75 years admitted to the ED for acute dyspnea
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240067


Contacts
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Contact: Omide TAHERI, MD 03.81.66.70.28 otaheri@chu-besancon.fr
Contact: Thibaut DESMETTRE, Prof, MD, PhD 03.81.66.88.37 tdesmettre@chu-besancon.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, Franche-Comté, France, 25000
Contact: Omide TAHERI, MD    03.81.66.70.28    otaheri@chu-besancon.fr   
Contact: Thibaut DESMETTRE, Prof., MD, PhD    03.81.66.88.37    tdesmettre@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Study Chair: Frédéric MAUNY, Prof, MD, PhD Centre Hospitalier Universitaire de Besancon
Study Chair: Noémie NMINEJ, PhD 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, PhD Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04240067    
Other Study ID Numbers: P/2019/466
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms