Acurate Heart Failure Clinical Trial
— ICA-MEESSIOfficial title:
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)
| NCT number | NCT04417881 |
| Other study ID # | 7880 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 19, 2020 |
| Est. completion date | June 23, 2021 |
| Verified date | October 2021 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department. European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.
| Status | Completed |
| Enrollment | 367 |
| Est. completion date | June 23, 2021 |
| Est. primary completion date | December 19, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Major patient - Patient admitted to emergencies with suspicion of ICA according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging - Patient with health insurance - Subject who accept to participate in the research Exclusion Criteria: - Patient who refuse to participate in the study - Patient with coronary syndrome with ST segment elevation - Other diagnosis of dyspnea - Persons deprived of their freedom or under the protection of justice - Persons under guardianship or curatorship - Impossibility of giving the patient informed information - Pregnant woman |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Jean Minjoz | Besançon | |
| France | Centre Hospitalier Jean Rougié | Cahors | |
| France | Hôpitaux Civils de Colmar | Colmar | |
| France | CH Haguenau | Haguenau | |
| France | Centre Hospitalier Forez | Montbrison | |
| France | CHU de Montpellier | Montpellier | |
| France | CHU de Nancy | Nancy | |
| France | CHU Pitié Salpetrière | Paris | |
| France | CHU de Reims | Reims | |
| France | CH Remiremont | Remiremont | |
| France | Hôpital Robert Pax | Sarreguemines | |
| France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| France | CHU Toulouse | Toulouse | |
| France | Hôpital Nord Franche Comté | Trévenans |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MEESSI score | Tscore to predict the patient's future in the month following management for ED ICA. That is to say the number of days alive outside the hospital in the month following an ICA episode. | 30 days | |
| Secondary | Re-admission rate | 30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score | 30 days | |
| Secondary | Mortality rate | Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score | 30 days | |
| Secondary | Sensitivity | Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories | 30 days |