Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU) (DOLORES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spaulding Christian, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01236157
First received: June 1, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation that when supported by the Mobile Services Emergency and Intensive Care (SMUR).

This ground of appeal underlying various pathologies especially acute coronary syndrome whose early care diagnostic and treatment significantly improves the prognosis.

The recognition and management of SCA is therefore a public health issue. Myocardial infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and coronary heart disease is the leading cause of death in France.

No studies have assessed the adequacy of regulation and management of chest pain SAMU for the diagnosis of SCA.

The main objective of the research is to have a descriptive analysis of the population controlled by the SAMU and the population served by the mobile emergency with chest pain. Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the final diagnosis and direction after passing emergency, cardiology and at follow-up to a year.


Condition
Chest Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Direction [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Matching the direction proposed by the ambulance and the final diagnosis


Enrollment: 1816
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chest Pain
All patients that call to the SAMU-ACS because of chest pain are included

Detailed Description:

Course of study:

  • Call the ambulance dispatch center: anamnestic data will be collected by the regulator on a medical report forms The patient is identified by an anonymous number, "number of SAMU business". The CRA of Centre concerned, from this number of case (using the database of SAMU) capture, in the database of the French Society of Cardiology - FSC - the patient identification data (name , surname, date of birth, address, telephone number and the name and address of attending physician, these data will be necessary for the CRA to the FSC to follow up to 1 year)
  • SMUR: if the patient arrives at SMUR, anamnestic data, clinical, laboratory, ECG, therapeutic, diagnostic and referral will be collected by the contact center on a paper CRF or on the computerized database of CFS by centers.
  • Emergency Service: If the patient comes to the ER, the clinical, laboratory, ECG, diagnostic output will be collected on a paper CRF or the computerized database of CFS according to the center by the referent of Centre concerned.
  • Cardiology service : if the patient arrives in the cardiology service, laboratory, ECG, diagnostic output will be collected on a paper CRF or the computerized database of CFS according to the center by the referring cardiologist DOLORES center.
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients that call to the SAMU-ACS because of chest pain

Criteria

Inclusion Criteria:

  • Patient who called UAS-ACS for a non-traumatic chest pain
  • Patient who agreed to participate in the study.

Exclusion Criteria:

  • Traumatic grief
  • Patient refusal to participate in the observatory
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236157

Locations
France
French Society of Cardiology
Paris, France
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Christian Spaulding AP-HP
  More Information

Publications:
Responsible Party: Spaulding Christian, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01236157     History of Changes
Other Study ID Numbers: 09365
Study First Received: June 1, 2010
Last Updated: June 13, 2012
Health Authority: France : National Commission on Informatics and Freedoms (CNIL)

Keywords provided by French Cardiology Society:
Cardiology

Additional relevant MeSH terms:
Chest Pain
Emergencies
Pain
Signs and Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014