Chest PainRaisDiagNCT02932982
Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain
An observational study of Chest Pain and Dyspnea, run by University Hospital, Brest at 11 sites in France.
Trial summary
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Pain, Dyspnea
- How many people
- 241 participants
- Where
- 11 sitesFrance
- Study dates
- 21 Oct 2016to 9 May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 18 and 80 years and consulting on primary care for chest pain or dyspnea
Who may be able to join
- Patients between 18 and 80 years
- Patients consulting on primary care for chest pain or dyspnea
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
ABALAIN-VOREUX Aurélie
Brest, 29200
SIMON Benjamin
Brest, 29200
AUFFRET Jean François
Camaret-sur-Mer, 29570
POINOT Anne
Guerlesquin, 29248
LE GOFF Delphine
La Forêt Landerneau, France, 29800
BEURTON-COURAUD Lucas
Pleyben, 29190
LE DUFF Nicolas
Ploudalmézeau, 29830
BODIN Bénédicte
Plounéour-Trez, 29890
CAM Françoise
Plouzané, 29280
LOSQUIN André
Pont-l'Abbé, 29120
MAHE Gwénaëlle
Saint-Nicolas-du-Pélem, 22480
About this study
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.
Read the detailed description
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.
The objective of the research is to calculate the precision of the sense of alarm the general practitioner facing a consultant for chest pain or dyspnea and patient
- Conditions
- Chest Pain, Dyspnea
- Keywords
- primary care, chest pain, dyspnea
- Medical subject headings
- Chest Pain, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
calculate the accuracy of the sense of alarm the general practitioner face a patient consultant for chest pain or dyspnea.
Questionary
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start21 Oct 2016
- Primary completion9 May 2018
- Study completion9 May 2018
Why it stopped: No more patients to include
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 Chest PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- University of Anvers, Ecole doctorale de Bretagne en biologie de santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932982
- Sponsor's protocol ID
- 29BRC16.0143
- Acronym
- RaisDiag
- Status last verified
- Nov 2018
- First submitted
- 12 Oct 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Barais M, Fossard E, Dany A, Montier T, Stolper E, Van Royen P. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020 Feb 18;10(2):e034348. doi: 10.1136/bmjopen-2019-034348.
PubMed 32075841
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Reasoning and Sense of Alarm at Dyspnoea and / or Chest Pain
- ClinicalTrials.gov ID
- NCT02932982
- Acronym / sponsor ID
- RaisDiag / 29BRC16.0143
- Conditions
- Chest Pain, Dyspnea
- Keywords
- primary care, chest pain, dyspnea
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more patients to include
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- University of Anvers, Ecole doctorale de Bretagne en biologie de santé
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 13 Oct 2016 (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.
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.
Detailed description
Dyspnea and chest pain represent 1.5% of general practice consultations. They may be a sign of many diseases, potentially serious. The concept of Gut Feelings brings a sense of alarm and reinsurance. The sense of alarm reflects a sense of mistrust about the patient's clinical situation, in the absence of objective argument. The sense of reinsurance reflects a sense of confidence about the patient's situation, in the absence of objective argument. Gut Feelings plays a key role in the diagnostic reasoning in general practice. A questionnaire measuring the Gut Feelings was validated in French after a linguistic validation procedure.
The objective of the research is to calculate the precision of the sense of alarm the general practitioner facing a consultant for chest pain or dyspnea and patient
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 80 years and consulting on primary care for chest pain or dyspnea
Key inclusion criteria (2 listed)
- Patients between 18 and 80 years
- Patients consulting on primary care for chest pain or dyspnea
Key exclusion criteria (0 listed)
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
calculate the accuracy of the sense of alarm the general practitioner face a patient consultant for chest pain or dyspnea.
Time frame: 4 weeks
Questionary
Results and safety
The study was stopped early (reason given: No more patients to include). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 32075841Barais M, Fossard E, Dany A, Montier T, Stolper E, Van Royen P. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020 Feb 18;10(2):e034348. doi: 10.1136/bmjopen-2019-034348.
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites 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 and Dyspnea, run by University Hospital, Brest at 11 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 0 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: stopped early, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: No more patients to include). Results are not available in the source record.
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?
calculate the accuracy of the sense of alarm the general practitioner face a patient consultant for chest pain or dyspnea. (time frame: 4 weeks). 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 NCT02932982, 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 20 Nov 2018.