Chest PaineCARENCT04157790
Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
A study testing CARE score in people with Chest Pain, run by University Hospital, Angers at 11 sites in 2 countries.
Trial summary
Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- CARE score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,153 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 10 Jan 2022to 19 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- Admission to an Emergency Department participating in the study
- Non-traumatic chest pain
- Age greater than or equal to 18 years
- Patient's consent (oral for France, written for Belgium)
Who cannot join
- 30 days follow-up not possible
- ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG
- Chest pain formally reported to a diagnosis other than an ACS before inclusion (e.g., pneumothorax, pleurisy, etc.)
- Troponin assay performed prior to inclusion (less than 24 hours old)
- Patient referred by another care structure (excluding primary medicine)
- Patient already included in study still in follow-up period
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- Pregnant, breastfeeding or parturient patient,
- Patient deprived of liberty by judicial or administrative decision,
- Patient undergoing psychiatric care under duress,
- Patient subject to a legal protection measure,
- Patient unable to give free and informed consent.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France9 sites
CHU Angers
Angers
Centre Hospitalier de Cholet
Cholet
CHD Vendée
La Roche-sur-Yon, 85925
CH Le Mans
Le Mans
Centre Hospitalier Universitaire de Rennes
Rennes
CH de Saint-Brieuc
Saint-Brieuc
CH de Saint-Malo
St-Malo
CHU Toulouse
Toulouse
CHU de Tours
Tours
About this study
Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations.
The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is <2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is > 1 (positive rule).
The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.
Read the detailed description
Data collected in this study are not anticipated to be published in a data repository. However, data will be shared per requested need to researchers, upon presentation of a structured protocol, when approved by the competent ethic committee and approved by the steering committee.
- Conditions
- Chest Pain
- Being tested
- CARE score
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE scoreOther
CARE score calculation
| Study group | Role | What they receive |
|---|---|---|
| Neutral | No intervention | Suggested to follow European Society of Cardiology guidelines for NSTEMI |
| CARE score | Active comparator | calculation of the CARE score and prescription for troponins assays or not according to the result (score > 1: troponins assays ; score < 2: no troponins assays) Receives: Other: CARE score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major cardiac events
Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest
Measured: 30 days
Secondary outcomes (3)
Rate of major cardiac events for the intention to treat study population
Measured: 30 days
Number of troponin assays in the intention to treat population
Measured: 2 days
Time spent in the emergency department in the intention to treat population
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start10 Jan 2022
- Primary completion5 May 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157790
- Sponsor's protocol ID
- 49RC19_0071
- Acronym
- eCARE
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moumneh T, Penaloza A, Charpentier S, Douillet D, Prunier F, Riou J, Roy PM. Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial. BMJ Open. 2022 Dec 6;12(12):e066953. doi: 10.1136/bmjopen-2022-066953.
PubMed 36600358
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the CARE Rule Associated With the HEART Score in Patients With Emergency Chest Pain
- ClinicalTrials.gov ID
- NCT04157790
- Acronym / sponsor ID
- eCARE / 49RC19_0071
- Conditions
- Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,153 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 8 Nov 2019 (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.
Acute coronary syndrome (ACS) is a major public health problem and its diagnosis remains a challenge for the emergency physician. The European Society of Cardiology recommends a troponin dosage and renew it if necessary during any suspicion of ACS. However, the criteria leading to initiate a diagnostic procedure during chest pain are imprecise. The fear is, on the one hand, to miss a potentially vital diagnosis and, on the other hand, to expose a large number of patients to unnecessary examinations.
The CARE rule (also known as HEAR score) seems to streamline this first step. It assigns a value of 0 to 2 using 4 items: Characteristic of pain, Age, Risk factors and Electrocardiogram (ECG). The search for an ACS is not justified if the sum of the points is <2 (negative rule) and, inversely, a troponin determination must be carried out if the sum is > 1 (positive rule).
The aim of the study is to demonstrate the safety and interest of the CARE rule associated with the HEART score to streamline ACS's diagnostic approach to thoracic pain in emergencies departments.
Detailed description
Data collected in this study are not anticipated to be published in a data repository. However, data will be shared per requested need to researchers, upon presentation of a structured protocol, when approved by the competent ethic committee and approved by the steering committee.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral | No intervention | –Suggested to follow European Society of Cardiology guidelines for NSTEMI |
| CARE score | Active comparator | Other: CARE scorecalculation of the CARE score and prescription for troponins assays or not according to the result (score > 1: troponins assays ; score < 2: no troponins assays) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to an Emergency Department participating in the study
- Non-traumatic chest pain
- Age greater than or equal to 18 years
- Patient's consent (oral for France, written for Belgium)
Key exclusion criteria (11 listed)
- 30 days follow-up not possible
- ST-segment Elevation Myocardial Infarction (STEMI) on admittance ECG
- Chest pain formally reported to a diagnosis other than an ACS before inclusion (e.g., pneumothorax, pleurisy, etc.)
- Troponin assay performed prior to inclusion (less than 24 hours old)
- Patient referred by another care structure (excluding primary medicine)
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 |
|---|---|---|
| CARE scoreCARE score calculation | Other | CARE score |
Primary outcome
Rate of major cardiac events
Time frame: 30 days
Myocardial infarction, percutaneous or surgical coronary reperfusion, certain or potential cardiac death, or surviving cardiac arrest
3 secondary outcomes
Rate of major cardiac events for the intention to treat study population
Time frame: 30 days
Number of troponin assays in the intention to treat population
Time frame: 2 days
Time spent in the emergency department in the intention to treat population
Time frame: 2 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 23 Oct 2023.
- Derived from this study: PubMed 36600358Moumneh T, Penaloza A, Charpentier S, Douillet D, Prunier F, Riou J, Roy PM. Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial. BMJ Open. 2022 Dec 6;12(12):e066953. doi: 10.1136/bmjopen-2022-066953.
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE score in people with Chest Pain, run by University Hospital, Angers at 11 sites in 2 countries.
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 11 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Belgium. 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?
Rate of major cardiac events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157790, which also lists 1 linked publication.
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 23 Oct 2023.