Chest Pain Nurse Track

NCT06149819 | Recruiting DMC

• 2 other identifiers: 38RC22.0276ID-RCB: 2023-A00058-37
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chest Pain

Keywords

non traumatic chest pain; Nurse; management; track

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (7)

• Time in minutes between admission to emergency department and realization of Electrocardiogram (EKG/ECG

  15 minutes

• Total duration in minutes of management in both cohorts between patient admission and effective patient discharge from emergency department.

  30 days

• All-cause care consumption in each cohort at one month

  30 days

• Rate of Major Adverse Cardiovascular Events (MACE) at one month in each cohort

  30 days

• Refusal rate of participation in the study in the paramedical cohort

  24 hours and 30 days

Study Arms (2)

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.

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.

Interventions

Diagnostic and safety of a nursing pathway for the management of non-traumatic chest pain OTHER

trained nurses will take in charge non-traumatic chest pain patient according to the standardized algorithm based on the recommendations .

Intervention (paramedical)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien VIGLINO

  Emergency Department of University Hospital Grenoble

  PRINCIPAL INVESTIGATOR

• Florian BARRET, Bachelor

  Emergency Department of University Hospital Grenoble

  STUDY DIRECTOR

• Karine FANJAS, Bachelor

  Emergency Department of University Hospital Grenoble

  STUDY DIRECTOR

Central Study Contacts

Damien VIGLINO, Pr MD PhD

CONTACT

0033476766784; DViglino@chu-grenoble.fr

Prudence MABIALA MAKELE, PhD

CONTACT

033476766784; pmabialamakele@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: at the time of publication
• Access Criteria: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. Moreover, In accordance with the French law n ° 2002-303 of March 4t, 2002

Locations

FR (1)