Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

Emergencies Clinical Trial

— MEESSI  

Official title:

Evaluation of the Impact of the MEESSI-AHF Scale on Decision Making and the Prognosis of Patients Diagnosed With Acute Heart Failure in the Emergency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919225
• Other study ID #: HCB/2018/0233
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Hospital Clinic of Barcelona
• Contact: Oscar Miro, PhD
• Phone: (+34)638274489
• Email: omiro[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the impact the application of the MESSI-AHF scale (a risk stratification scale specifically derived and validated in patients diagnosed with acute heart failure, AHF) in decision making (admission vs. discharge) by emergency physicians in emergency departments (ED) and its potential impact on on the short-term prognosis of patients with AHF.

Description:

Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of AHF based on Framinham criteria

• NT-proBNP >300 pg/mL

• Patient able to consent

Exclusion Criteria:

• ST-elevation acute coronary syndrome

Related Conditions & MeSH terms

• Acute Heart Failure
• Emergencies
• Heart Failure

Intervention

Procedure:
• Risk stratification before decision-making about patient hospitalization or discharge
Once AHF has been diagnosed at ED, and before decision-making about hospitalize/discharge home is taken, physicians will objectively measure the severity of decompensation, based on risk of 30-day death using MEESSI scale. As result, patient can be allocated to low, intermediate, high or very-high risk. For patients classified as low-risk, the propocol recommendation will be discharge patient to home. For patients classified as increased risk (i.e., intermediate, high or very-high risk categories), the protocol recommendation will be to hospitalize patient. Nonetheless, final decission will be left to emergency physician, and overruling (disposition against recommendation) will be allowed.

Locations

Country	Name	City	State
Spain	Emergency Department, Hospital de Albacete	Albacete
Spain	Emergency Department, Hospital Dr. Balmis	Alicante
Spain	Emergency department	Barcelona	Catalonia
Spain	Emergency Department, Hospital de Sant Pau	Barcelona
Spain	Emergency Department, Hospital del Mar	Barcelona
Spain	Emergency Department, Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Emergency Department, Hospital La Mancha	Ciudad Real
Spain	Emergency Department, Hospital de Gandia	Gandia	Valencia
Spain	Emergency Department, Hospital de Getafe	Getafe	Madrid
Spain	Emergency Department, Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Emergency Department, Hospital Dr. Gregorio Marañón	Madrid
Spain	Emergency Department, Hospital Infanta Leonor	Madrid
Spain	Emergency Department, Hospital de Móstoles	Móstoles	Madrid
Spain	Emergency Department, Hospital de Salamanca	Salamanca
Spain	Emergency Department, Hospital Marques de Valdecilla	Santander
Spain	Emergency Department, Hospital Sant Pau i Santa Tecla	Tarragona
Spain	Emergency Department, Hospital Dr. Peset	Valencia
Spain	Emergency Department, Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Miro O, Gil V, Rossello X, Martin-Sanchez FJ, Llorens P, Jacob J, Herrero P, Herrera Mateo S, Richard F, Escoda R, Fuentes M, Martin Mojarro E, Llauger L, Bueno H, Pocock S. Patients with acute heart failure discharged from the emergency department and cl — View Citation

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero P, Jacob J, Lopez-Grima ML, Gil C, Lucas Imbernon FJ, Garrido JM, Perez-Dura MJ, Lopez-Diez MP, Richard F, Bueno H, Pocock SJ. The Usefulness of the MEESSI Score for Risk Stratification of P — View Citation

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Bueno H, Pocock SJ; ICA-SEMES Research Group. Predicting 30-Day Mortality for Patients With Acute Heart Failure in the Emergency Department: A Cohort Study. Ann Intern Med — View Citation

Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Pinera P, Mojarro EM, Lucas-Imbernon FJ, Llauger L, Aguera C, Lopez-Diez MP, Valero A, Bueno H, Pocock SJ; ICA-SEMES Research Group. Analysis of How Emergency Physicians' — View Citation

Rossello X, Bueno H, Gil V, Jacob J, Javier Martin-Sanchez F, Llorens P, Herrero Puente P, Alquezar-Arbe A, Raposeiras-Roubin S, Lopez-Diez MP, Pocock S, Miro O. MEESSI-AHF risk score performance to predict multiple post-index event and post-discharge sho — View Citation

Wussler D, Kozhuharov N, Sabti Z, Walter J, Strebel I, Scholl L, Miro O, Rossello X, Martin-Sanchez FJ, Pocock SJ, Nowak A, Badertscher P, Twerenbold R, Wildi K, Puelacher C, du Fay de Lavallaz J, Shrestha S, Strauch O, Flores D, Nestelberger T, Boeddingh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of causes of overruling	Causes of overruling will be analyzed	Through study completion, an avarage of 1 year
Other	Sensitivity analysis per protocol	All previous analyses will be made just using patients of the intervention arm that were managed according to recommendation provided after risk stratification with MEESSI scale (i.e., disregarding patients for whom recommendation was overruled by the emergency physician)	Through study completion, an avarage of 1 year
Primary	30-day all cause death	Death for any cause since patient randomization (day 0) to day 30	Through study completion, an avarage of 1 year
Primary	Days alive and out of hospital	Number of days with patient staying out of hospital (it can be at home, et residencial nursing house, etc., but not at hospital) from randomization (day 0) to day 30.	Through study completion, an avarage of 1 year
Secondary	Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)	Event will be considered if patient present ED revisit due to AHF, hospitalization due to AHF or all-cause death from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.	Through study completion, an avarage of 1 year
Secondary	ED revisit due to AHF within the 30 days after discharge	Event will be considered if patient present ED revisit due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.	Through study completion, an avarage of 1 year
Secondary	Hospitalization due to AHF within the 30 days after discharge	Event will be considered if patient is hospitalized due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.	Through study completion, an avarage of 1 year
Secondary	All-cause death within the 30 days after discharge	Event will be considered if patient dies from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.	Through study completion, an avarage of 1 year
Secondary	Proportion of patients with AHF managed without hospitalization.	We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization	Through study completion, an avarage of 1 year