Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-05 @ 6:00 PM
Study NCT ID:
NCT01236157
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1816}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Direction', 'timeFrame': '1 day', 'description': 'Matching the direction proposed by the ambulance and the final diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiology'], 'conditions': ['Chest Pain']}, 'referencesModule': {'references': [{'pmid': '16311237', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1895047', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16379109', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12503543', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16379105', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25662700', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThis ground of appeal underlying various pathologies especially acute coronary syndrome whose early care diagnostic and treatment significantly improves the prognosis.\n\nThe 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.\n\nNo studies have assessed the adequacy of regulation and management of chest pain SAMU for the diagnosis of SCA.\n\nThe 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.', 'detailedDescription': 'Course of study:\n\n* 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)\n* 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.\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that call to the SAMU-ACS because of chest pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who called UAS-ACS for a non-traumatic chest pain\n* Patient who agreed to participate in the study.\n\nExclusion Criteria:\n\n* Traumatic grief\n* Patient refusal to participate in the observatory'}, 'identificationModule': {'nctId': 'NCT01236157', 'acronym': 'DOLORES', 'briefTitle': 'Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)', 'orgStudyIdInfo': {'id': '09365'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chest Pain', 'description': 'All patients that call to the SAMU-ACS because of chest pain are included'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'French Society of Cardiology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Christian Spaulding', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Spaulding Christian', 'investigatorAffiliation': 'French Cardiology Society'}}}}