- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236157
Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU) (DOLORES)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France
- French Society of Cardiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chest Pain
All patients that call to the SAMU-ACS because of chest pain are included
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Direction
Time Frame: 1 day
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Matching the direction proposed by the ambulance and the final diagnosis
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Spaulding, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, De Feyter PJ, Specchia G, Ruzyllo W; Task Force on the Management of Acute Coronary Syndromes of the European Society of Cardiology. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2002 Dec;23(23):1809-40. doi: 10.1053/euhj.2002.3385. No abstract available. Erratum In: Eur Heart J. 2003 Jun;24(12):1174-5. Eur Heart J. 2003 Mar;24(5):485.
- Bassand JP, Danchin N, Filippatos G, Gitt A, Hamm C, Silber S, Tubaro M, Weidinger F. Implementation of reperfusion therapy in acute myocardial infarction. A policy statement from the European Society of Cardiology. Eur Heart J. 2005 Dec;26(24):2733-41. doi: 10.1093/eurheartj/ehi673. Epub 2005 Nov 25.
- Karlson BW, Herlitz J, Pettersson P, Ekvall HE, Hjalmarson A. Patients admitted to the emergency room with symptoms indicative of acute myocardial infarction. J Intern Med. 1991 Sep;230(3):251-8. doi: 10.1111/j.1365-2796.1991.tb00439.x.
- Assez N, Adriansen C, Charpentier S, Baixas C, Ducasse JL, Goldstein P. [Management of acute coronary syndromes without ST elevation: the TOSCANE registry]. Arch Mal Coeur Vaiss. 2005 Nov;98(11):1123-9. French.
- Sauval P, Bout H, Ohanessian A, Danchin N, Monsegu J, Varenne O, Carli P, Spaulding C. [Management of chest pain by the Emergency Ambulance Service: the DOLORES register]. Arch Mal Coeur Vaiss. 2005 Nov;98(11):1095-9. French.
- Manzo-Silberman S, Assez N, Vivien B, Tazarourte K, Mokni T, Bounes V, Greffet A, Bataille V, Mulak G, Goldstein P, Ducasse JL, Spaulding C, Charpentier S. Management of non-traumatic chest pain by the French Emergency Medical System: Insights from the DOLORES registry. Arch Cardiovasc Dis. 2015 Mar;108(3):181-8. doi: 10.1016/j.acvd.2014.11.002. Epub 2015 Feb 7. Erratum In: Arch Cardiovasc Dis. 2015 May;108(5):333-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09365
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