Acurate Heart FailureICA-MEESSINCT04417881
EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES
An observational study of Acurate Heart Failure, run by University Hospital, Strasbourg, France at 14 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acurate Heart Failure
- What is being tested?
- MEESSI score
- How many people
- 367 participants
- Where
- 14 sitesFrance
- Study dates
- 19 Dec 2020to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to emergencies with suspicion of ICA
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Hôpital Jean Minjoz
Besançon, 25030
Centre Hospitalier Jean Rougié
Cahors, 46005
Hôpitaux Civils de Colmar
Colmar, 68000
CH Haguenau
Haguenau, 67500
Centre Hospitalier Forez
Montbrison, 42605
CHU de Montpellier
Montpellier, 34295
CHU de Nancy
Nancy, 54035
CHU Pitié Salpetrière
Paris, 75013
CHU de Reims
Reims, 51100
CH Remiremont
Remiremont, 88200
Hôpital Robert Pax
Sarreguemines, 57200
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
CHU Toulouse
Toulouse, 31300
Hôpital Nord Franche Comté
Trévenans, 90400
About this study
Official 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)
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.
- Conditions
- Acurate Heart Failure
- Being tested
- MEESSI score
- Keywords
- caring, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEESSI scoreOther
MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.
| Study group | Role | What they receive |
|---|---|---|
| patients with acurate heart failure | Not described Receives: Other: MEESSI score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Re-admission rate
30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score
Measured: 30 days
Mortality rate
Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score
Measured: 30 days
Sensitivity
Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start19 Dec 2020
- Primary completion19 Dec 2020
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acurate Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417881
- Sponsor's protocol ID
- 7880
- Acronym
- ICA-MEESSI
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04417881
- Acronym / sponsor ID
- ICA-MEESSI / 7880
- Conditions
- Acurate Heart Failure
- Keywords
- caring, emergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acurate heart failure | – | Other: MEESSI score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to emergencies with suspicion of ICA
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEESSI scoreMEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department. | Other | patients with acurate heart failure |
Primary outcome
MEESSI score
Time frame: 30 days
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.
3 secondary outcomes
Re-admission rate
Time frame: 30 days
Mortality rate
Time frame: 30 days
Sensitivity
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acurate Heart Failure, run by University Hospital, Strasbourg, France at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEESSI score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021; AzTrials last refreshed its copy on 4 Nov 2026.