Chest PainCHESTNUTNCT06149819
Chest Pain Nurse Track
A study testing Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain in people with Chest Pain, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Chest pain is a commonly encountered presentation in the emergency department (ED), with an incidence ranging from 5 to 12%. Chest pain has a wide range of aetiologies from the mildest to the most severe. 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?
- Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2023to 14 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 emergency department (ED) for non-traumatic Chest Pain
- Affiliation to the French social security system
- Written informed consent must be obtained
- For women of childbearing age: effective contraception in place for at least 3 months. The absence of pregnancy should be confirmed by a negative urine test without delaying the start of the management including the realization of Electrocardiogram (EKG/ECG).
Who cannot join
- Suspected alcohol, drug or toxic intoxication
- Chest pain with associated neurological signs
- Patient with pacemaker or defibrillator
- Patient in vital distress requiring immediate medical intervention
- Patient admitted with a previously established aetiological diagnosis
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- Pregnant or breast-feeding patients
- Subject under administrative or judicial control, under protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, Grenoble, 38043
Damien VIGLINO
About this study
Official title: Nurse Pathway for the Diagnosis of Non-traumatic Chest Pain in the Emergency Department: Preliminary Pilot Study (Chest Pain Nurse Track)
Chest pain is a commonly encountered presentation in the emergency department (ED), with an incidence ranging from 5 to 12%. Chest pain has a wide range of aetiologies from the mildest to the most severe. In benign forms these pains can be musculoskeletal, psychogenic or even indeterminate (>60% depending on the place of recruitment). Coronary aetiology represents 12 to 25% of severe forms.
The management of chest pain in the emergency department is part of the daily life of nurses. According to the french 2020 Nurse Reception Organizer (IOA) guidelines, a nurse who has been trained for this role is required to "triage" (severity grade and orientation) patients presenting for this reason. The presence of specialized nurses in the management of chest pain allows faster initial management.
To date, no study has been conducted to assess the diagnostic and treatment performance of a nursing pathway for the management of patients presenting with acute chest pain regardless of the suspected diagnosis and not only acute coronary syndrome.
Read the detailed description
The main objective of this interventional study is to evaluate the diagnostic safety of a nursing pathway for the management of patients presenting with chest pain in the emergency department compared with usual medical care.
This study is an external comparison with a control group consisting of patients meeting the eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio.
The study will be conducted in three phases :
- Training volunteer emergency department nurses (11) : the course will cover all aspects of management of non-traumatic chest pain (physiopathology, from diagnosis to treatment). For the selection of nurses, these criteria will need to be met : minimum of five years of practice in the profession with at least three years in emergency department ; the nurse must have had the training as a Nurse Reception Organizer and have received specific training in accordance with the study protocol.
- Enrollment of 182 patients admitted to the emergency department for non-traumatic chest pain. The patient will be enrolled either in the experimental (paramedical) or control (medical) group. 91 patients will be included in each group. Experimental (Intervention) group or (paramedical cohort) : The patient is cared for by one of the specially trained nurses based on a previously established allocation per day. A nurse will be able to take in charge several patients successively included on the same day, in accordance with the actual practice of organized intra-hospital sector. The nurse will manage the patient according to the standardized algorithm based on the recommendations. An emergency physician will be systematically involved in the management process for interpretation of electrocardiogram (EKG) and chest x-ray, during a positive diagnosis, a sign of gravity and finally at any time as soon as the nurse considers it necessary. In addition each patient will be systematically examined and reassessed by a physician during paramedical management to validate the clinical, therapeutic and discharges conclusions. Control group (or medical cohort) : Cohort of patients receiving usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients in this group will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years). An independent adjudication committee comprising at least one emergency physician and one cardiologist will be responsible for analyzing the medical records of all patients (included in the two groups) in order to determine compliance with diagnostic management. It will meet before each Data and Safety Monitoring Board (DSMB) meeting (at 20, 50 and 80%) and at the end of the study. Data and Safety Monitoring Board (DSMB)composed of a methodologist, a cardiologist and an emergency physician. The DSMB will be responsible for analyzing the compliance and safety of management in the experimental group at 20, 50 and 80% of enrollment and at the request of the sponsor if necessary. This committee will also analyze the one month outcome of the patients included. It will decide whether to prosecute or stop the study.
- Phone call follow-up of patient after one month to collect data :
- Intercurrent serious events : death, re-admission, myocardial infarction, serious AE
- Assessment of patient satisfaction
- Any additional examinations and consultations carried out.
- Conditions
- Chest Pain
- Being tested
- Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain
- Keywords
- non traumatic chest pain, Nurse, management, track
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic and safety of a nursing pathway for the management of non-traumatic chest painOther
trained nurses will take in charge non-traumatic chest pain patient according to the standardized algorithm based on the recommendations .
| Study group | Role | What they receive |
|---|---|---|
| Intervention (paramedical) | Experimental | The patients will be cared for by one of the specially trained nurses based on a previously established allocation per day. A nurse will be able to take in charge several patients successively included on the same day, in accordance with the actual practice of organized intra-hospital sector and according to the standardized algorithm based on the recommendations.
The DSMB will analyzed the compliance and safety of the management in this group at 20, 50 and 50% of enrollment and at the request of the sponsor if necessary.
An adjudication committee will determine compliance with diagnostic management in the two groups. Receives: Other: Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain |
| Control (medical) | No intervention | In this group the patients will received usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years). An adjudication committee will determine compliance with diagnostic management in the two groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care.
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care after adjudication by an expert committee.
Measured: 30 days
Secondary outcomes (7)
Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG
Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG
Measured: 15 minutes
Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department.
Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department .
Measured: 30 days
All-cause care consumption in each cohort at one month
All-cause care consumption in each cohort at one month
Measured: 30 days
Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort
Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort
Measured: 30 days
Refusal rate of participation in the study in the paramedical cohort
Refusal rate of participation in the study in the paramedical cohort
Measured: 24 hours and 30 days
Patient satisfaction assessed during discharge and at one month in both cohort
Patient satisfaction assessed during discharge and at one month by a numerical scale in both cohort numbered from 1 to 10 : (Not satisfied patient would no longer accept a nurse's care - Completely satisfied patient would accept to be cared for again by a nurse)
Measured: 24 hours and 30 days
Assessment of quality of life during discharge and at one month in both cohort
Assessment of quality of life using EuroQol 5-dimension scale at discharge from emergency department and at one month in both cohort numbered from 0 to 100 : (the worst health you can imagine -the best health you can imagine)
Measured: 24 hours and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start14 Dec 2023
- Primary completion14 Jul 2027 (estimated)
- Study completion14 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- This is a controlled, single centre, non-randomized, open-label interventional study evaluating the implementation of a nursing pathway management for chest pain. This study is an external comparison with a control group consisting of patients meeting the same eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio. This design was chosen because of the difficulty of randomizing patients (few trained nurses) and the need to conduct a pivotal study.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien VIGLINO, Principal investigator, Emergency Department of University Hospital GrenobleFlorian BARRET, Bachelor, Study director, Emergency Department of University Hospital GrenobleKarine FANJAS, Bachelor, Study director, Emergency Department of University Hospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149819
- Sponsor's protocol ID
- 38RC22.0276
- Other IDs
- ID-RCB: 2023-A00058-37
- Acronym
- CHESTNUT
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Pathway for the Diagnosis of Non-traumatic Chest Pain in the Emergency Department: Preliminary Pilot Study (Chest Pain Nurse Track)
- ClinicalTrials.gov ID
- NCT06149819
- Acronym / sponsor ID
- CHESTNUT / 38RC22.0276
- Conditions
- Chest Pain
- Keywords
- non traumatic chest pain, Nurse, management, track
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 14 Dec 2027 (estimated)
- First posted
- 29 Nov 2023 (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.
Chest pain is a commonly encountered presentation in the emergency department (ED), with an incidence ranging from 5 to 12%. Chest pain has a wide range of aetiologies from the mildest to the most severe. In benign forms these pains can be musculoskeletal, psychogenic or even indeterminate (>60% depending on the place of recruitment). Coronary aetiology represents 12 to 25% of severe forms.
The management of chest pain in the emergency department is part of the daily life of nurses. According to the french 2020 Nurse Reception Organizer (IOA) guidelines, a nurse who has been trained for this role is required to "triage" (severity grade and orientation) patients presenting for this reason. The presence of specialized nurses in the management of chest pain allows faster initial management.
To date, no study has been conducted to assess the diagnostic and treatment performance of a nursing pathway for the management of patients presenting with acute chest pain regardless of the suspected diagnosis and not only acute coronary syndrome.
Detailed description
The main objective of this interventional study is to evaluate the diagnostic safety of a nursing pathway for the management of patients presenting with chest pain in the emergency department compared with usual medical care.
This study is an external comparison with a control group consisting of patients meeting the eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio.
The study will be conducted in three phases :
- Training volunteer emergency department nurses (11) : the course will cover all aspects of management of non-traumatic chest pain (physiopathology, from diagnosis to treatment). For the selection of nurses, these criteria will need to be met : minimum of five years of practice in the profession with at least three years in emergency department ; the nurse must have had the training as a Nurse Reception Organizer and have received specific training in accordance with the study protocol.
- Enrollment of 182 patients admitted to the emergency department for non-traumatic chest pain. The patient will be enrolled either in the experimental (paramedical) or control (medical) group. 91 patients will be included in each group. Experimental (Intervention) group or (paramedical cohort) : The patient is cared for by one of the specially trained nurses based on a previously established allocation per day. A nurse will be able to take in charge several patients successively included on the same day, in accordance with the actual practice of organized intra-hospital sector. The nurse will manage the patient according to the standardized algorithm based on the recommendations. An emergency physician will be systematically involved in the management process for interpretation of electrocardiogram (EKG) and chest x-ray, during a positive diagnosis, a sign of gravity and finally at any time as soon as the nurse considers it necessary. In addition each patient will be systematically examined and reassessed by a physician during paramedical management to validate the clinical, therapeutic and discharges conclusions. Control group (or medical cohort) : Cohort of patients receiving usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients in this group will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years). An independent adjudication committee comprising at least one emergency physician and one cardiologist will be responsible for analyzing the medical records of all patients (included in the two groups) in order to determine compliance with diagnostic management. It will meet before each Data and Safety Monitoring Board (DSMB) meeting (at 20, 50 and 80%) and at the end of the study. Data and Safety Monitoring Board (DSMB)composed of a methodologist, a cardiologist and an emergency physician. The DSMB will be responsible for analyzing the compliance and safety of management in the experimental group at 20, 50 and 80% of enrollment and at the request of the sponsor if necessary. This committee will also analyze the one month outcome of the patients included. It will decide whether to prosecute or stop the study.
- Phone call follow-up of patient after one month to collect data :
- Intercurrent serious events : death, re-admission, myocardial infarction, serious AE
- Assessment of patient satisfaction
- Any additional examinations and consultations carried out.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a controlled, single centre, non-randomized, open-label interventional study evaluating the implementation of a nursing pathway management for chest pain. This study is an external comparison with a control group consisting of patients meeting the same eligibility criteria admitted to the Emergency Department over the same period and included prospectively with a 1:1 ratio. This design was chosen because of the difficulty of randomizing patients (few trained nurses) and the need to conduct a pivotal study.
| Arm | Type | Receives |
|---|---|---|
| Intervention (paramedical) | Experimental | Other: Diagnostic and safety of a nursing pathway for the management of non-traumatic chest painThe patients will be cared for by one of the specially trained nurses based on a previously established allocation per day. A nurse will be able to take in charge several patients successively included on the same day, in accordance with the actual practice of organized intra-hospital sector and according to the standardized algorithm based on the recommendations. The DSMB will analyzed the compliance and safety of the management in this group at 20, 50 and 50% of enrollment and at the request of the sponsor if necessary. An adjudication committee will determine compliance with diagnostic management in the two groups. |
| Control (medical) | No intervention | –In this group the patients will received usual medical care over the same period in the emergency department and meeting eligibility criteria. Patients will be included prospectively after obtaining their consent, with a 1:1 ratio with sex and age correspondence +/- 5 years). An adjudication committee will determine compliance with diagnostic management in the two groups. |
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 emergency department (ED) for non-traumatic Chest Pain
- Affiliation to the French social security system
- Written informed consent must be obtained
- For women of childbearing age: effective contraception in place for at least 3 months. The absence of pregnancy should be confirmed by a negative urine test without delaying the start of the management including the realization of Electrocardiogram (EKG/ECG).
Key exclusion criteria (8 listed)
- Suspected alcohol, drug or toxic intoxication
- Chest pain with associated neurological signs
- Patient with pacemaker or defibrillator
- Patient in vital distress requiring immediate medical intervention
- Patient admitted with a previously established aetiological diagnosis
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 |
|---|---|---|
| Diagnostic and safety of a nursing pathway for the management of non-traumatic chest paintrained nurses will take in charge non-traumatic chest pain patient according to the standardized algorithm based on the recommendations . | Other | Intervention (paramedical) |
Primary outcome
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care.
Time frame: 30 days
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care after adjudication by an expert committee.
7 secondary outcomes
Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG
Time frame: 15 minutes
Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department.
Time frame: 30 days
All-cause care consumption in each cohort at one month
Time frame: 30 days
Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort
Time frame: 30 days
Refusal rate of participation in the study in the paramedical cohort
Time frame: 24 hours and 30 days
Patient satisfaction assessed during discharge and at one month in both cohort
Time frame: 24 hours and 30 days
Assessment of quality of life during discharge and at one month in both cohort
Time frame: 24 hours and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
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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.
Damien VIGLINO principal investigator
Emergency Department of University Hospital Grenoble
Florian BARRET, Bachelor study director
Emergency Department of University Hospital Grenoble
Karine FANJAS, Bachelor study director
Emergency Department of University Hospital Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain in people with Chest Pain, run by University Hospital, Grenoble at 1 site 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 8 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien VIGLINO, Pr MD PhD (0033476766784, DViglino@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who benefited from a diagnosis and overall management in accordance with medical recommendations in the paramedical group compared with usual medical care. (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 20 Apr 2026.