Acute Coronary SyndromeDOREMI2NCT02042209
Medical Telephone Triage of Emergency Calls for Thoracic Pain
An observational study of Acute Coronary Syndrome, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 4,205 participants
- Where
- 3 sitesFrance
- Study dates
- May 2010to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years, with a non-traumatic chest pain.
Who may be able to join
- Patient presenting a non-traumatic chest pain.
- Call to the telephone triage center in first (direct call from the patient) or second intention (call of another person before the patient)
Who cannot join
- Inability to speak directly to the patient
Trial locations and contacts
3 sites in 1 country.
France3 sites
Bordeaux Hospital Center
Bordeaux, 33000
La Réunion Hospital center
Saint-Denis, 97405
Toulouse Hosital Center
Toulouse, 31000
About this study
Official title: Medical Telephone Triage of Emergency Calls for Thoracic Pain: Construction of a Probability Score for Acute Coronary Syndrome.
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis.
The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.
Read the detailed description
In France, approximately 30% of the calls for thoracic pain associated with an ACS do not benefit from the sending of an UMH. Our assumption is that this situation could be improved if telephone triage physicians were guided by recommendations or consensual algorithms of decision. The telephone triage doctor will manage a single questionnaire with the patient, with demographic and simple clinical data. The construction of the score will be done by the analysis of these data confronted with the final diagnosis (effective ACS or not). The effective existence of an ACS among patients with thoracic pain will be affirmed by an expert committee after collection of the intra-hospital patient's data and the follow-up at one month.
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, thoracic pain, prehospital, diagnostic score
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of acute coronary syndrome (ACS)
The criterion selected to build these scores will be the effective existence of an ACS among included patients.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 4,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis DUCASSE, PH, MD, Principal investigator, Toulouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042209
- Sponsor's protocol ID
- 0903508
- Other IDs
- PHRC interégional 2009
- Acronym
- DOREMI2
- Status last verified
- Jul 2020
- First submitted
- 17 Jan 2014
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Reuter PG, Pradeau C, Huo Yung Kai S, Lhermusier T, Bourde A, Tentillier E, Combes X, Bongard V, Ducasse JL, Charpentier S. Predicting acute coronary syndrome in males and females with chest pain who call an emergency medical communication centre. Scand J Trauma Resusc Emerg Med. 2019 Oct 17;27(1):92. doi: 10.1186/s13049-019-0670-y.
PubMed 31623657
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Telephone Triage of Emergency Calls for Thoracic Pain: Construction of a Probability Score for Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT02042209
- Acronym / sponsor ID
- DOREMI2 / 0903508
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, thoracic pain, prehospital, diagnostic score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,205 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jan 2014 (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.
Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis.
The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.
Detailed description
In France, approximately 30% of the calls for thoracic pain associated with an ACS do not benefit from the sending of an UMH. Our assumption is that this situation could be improved if telephone triage physicians were guided by recommendations or consensual algorithms of decision. The telephone triage doctor will manage a single questionnaire with the patient, with demographic and simple clinical data. The construction of the score will be done by the analysis of these data confronted with the final diagnosis (effective ACS or not). The effective existence of an ACS among patients with thoracic pain will be affirmed by an expert committee after collection of the intra-hospital patient's data and the follow-up at one month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years, with a non-traumatic chest pain.
Key inclusion criteria (2 listed)
- Patient presenting a non-traumatic chest pain.
- Call to the telephone triage center in first (direct call from the patient) or second intention (call of another person before the patient)
Key exclusion criteria (1 listed)
- Inability to speak directly to the patient
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
diagnosis of acute coronary syndrome (ACS)
Time frame: one month
The criterion selected to build these scores will be the effective existence of an ACS among included patients.
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 29 Jul 2020.
- Results publication: PubMed 31623657Reuter PG, Pradeau C, Huo Yung Kai S, Lhermusier T, Bourde A, Tentillier E, Combes X, Bongard V, Ducasse JL, Charpentier S. Predicting acute coronary syndrome in males and females with chest pain who call an emergency medical communication centre. Scand J Trauma Resusc Emerg Med. 2019 Oct 17;27(1):92. doi: 10.1186/s13049-019-0670-y.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Louis DUCASSE, PH, MD principal investigator
Toulouse Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University Hospital, Toulouse at 3 sites 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 1 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
diagnosis of acute coronary syndrome (ACS) (time frame: one month). 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 NCT02042209, which also lists 1 linked publication.
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 29 Jul 2020.