Chest PainDOLORESNCT01236157
Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)
An observational study of Chest Pain, run by French Cardiology Society at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 1,816 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that call to the SAMU-ACS because of chest pain
Who may be able to join
- Patient who called UAS-ACS for a non-traumatic chest pain
- Patient who agreed to participate in the study.
Who cannot join
- Traumatic grief
- Patient refusal to participate in the observatory
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Chest Pain
- Keywords
- Cardiology
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chest Pain | All patients that call to the SAMU-ACS because of chest pain are included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direction
Matching the direction proposed by the ambulance and the final diagnosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,816 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spaulding Christian, French Cardiology Society
- Investigators
- Christian Spaulding, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236157
- Sponsor's protocol ID
- 09365
- Acronym
- DOLORES
- Status last verified
- Aug 2019
- First submitted
- 1 Jun 2010
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16311237Karlson 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.
PubMed 1895047Assez 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.
PubMed 16379109Bertrand 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.
PubMed 12503543Sauval 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.
PubMed 16379105Manzo-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.
PubMed 25662700
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)
- ClinicalTrials.gov ID
- NCT01236157
- Acronym / sponsor ID
- DOLORES / 09365
- Conditions
- Chest Pain
- Keywords
- Cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,816 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Nov 2010 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest Pain | – | –All patients that call to the SAMU-ACS because of chest pain are included |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that call to the SAMU-ACS because of chest pain
Key inclusion criteria (2 listed)
- Patient who called UAS-ACS for a non-traumatic chest pain
- Patient who agreed to participate in the study.
Key exclusion criteria (2 listed)
- Traumatic grief
- Patient refusal to participate in the observatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Direction
Time frame: 1 day
Matching the direction proposed by the ambulance and the final diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 16311237Bassand 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.
- Background: PubMed 1895047Karlson 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.
- Background: PubMed 16379109Assez 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.
- Background: PubMed 12503543Bertrand 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.
- Background: PubMed 16379105Sauval 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.
- Results publication: PubMed 25662700Manzo-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.
Related trials for Chest Pain
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
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. This study is not recruiting at the moment.
Christian Spaulding principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by French Cardiology Society 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direction (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236157, which also lists 6 linked publications.
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 7 Aug 2019.