Noncardiac Chest PainNCT02405052
Validation of the Panic Screening Score in Patient With Unexplained Chest Pain
An observational study of Noncardiac Chest Pain and Panic Attack, run by CISSS de Chaudière-Appalaches at 1 site in Canada.
Trial summary
Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noncardiac Chest Pain, Panic Attack
- How many people
- 3,000 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Dec 2015
- 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 in the emergency department
Who may be able to join
- Presenting unexplained chest pain as defined by:
- the absence of an identifiable cause (e.g., pneumothorax,pneumonia),
- the absence of chest trauma,
- the absence of new malignant cardiac arrhythmia, and
- a score of 2 or less on the modified version of the thrombolysis in myocardial infarction score.
Who cannot join
- presence of a terminal illness;
- presence of a severe communication problem that could interfere with the administration of the questionnaire;
- presence of a psychotic state, a major cognitive deficit or other condition that could invalidate the interview;
- being legally incompetent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche, CSSS Alphonse-Desjardins, Centre hospitalier affilié universitaire de Lévis
Lévis, Quebec, G6V 3Z1
Guillaume Foldes-Busque, Ph.D, 418-835-7121 ext. 1519, guillaume.Foldes-Busque@psy.ulaval.ca
About this study
Official title: A Prospective Cohort Study to Refine and Validate the Panic Screening Score for Identifying Panic Attacks Associated With Unexplained Chest Pain in the Emergency Department
Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Panic-like anxiety may be responsible for a significant portion of the negative consequences of unexplained chest pain, such as functional limitations and chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time of discharge from the emergency department. The 4-item Panic Screening Score questionnaire was derived in order to increase the identification of panic-like anxiety in emergency department patients with unexplained chest pain.
The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2) validate the revised version of the Panic Screening Score; (3) measure the reliability of the revised version of the Panic Screening Score and (4) assess the acceptability of the instrument among emergency physicians.
- Conditions
- Noncardiac Chest Pain, Panic Attack
- Being tested
- No intervention
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Validation of the Panic Screening Score
| Study group | Role | What they receive |
|---|---|---|
| Patients | Emergency department patients with unexplained chest pain Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Panic Screening Score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2015 (estimated)
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 Noncardiac 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CISSS de Chaudière-Appalaches
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Guillaume Foldes-Busque, CISSS de Chaudière-Appalaches
- Investigators
- Guillaume Foldes-Busque, Ph.D, Principal investigator, Centre hospitalier affilié universitaire de Lévis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405052
- Sponsor's protocol ID
- 286934
- Status last verified
- Mar 2015
- First submitted
- 29 Mar 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
Publications
Foldes-Busque G, Denis I, Poitras J, Fleet RP, Archambault P, Dionne CE. A prospective cohort study to refine and validate the Panic Screening Score for identifying panic attacks associated with unexplained chest pain in the emergency department. BMJ Open. 2013 Oct 25;3(10):e003877. doi: 10.1136/bmjopen-2013-003877.
PubMed 24163208
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Refine and Validate the Panic Screening Score for Identifying Panic Attacks Associated With Unexplained Chest Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT02405052
- Acronym / sponsor ID
- 286934
- Conditions
- Noncardiac Chest Pain, Panic Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- CISSS de Chaudière-AppalachesOther government
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 1 Apr 2015 (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.
Panic-like anxiety ( panic attacks with or without panic disorder), a highly treatable condition, is the most prevalent condition associated with unexplained chest pain in the emergency department. Panic-like anxiety may be responsible for a significant portion of the negative consequences of unexplained chest pain, such as functional limitations and chronicity. However, more than 92% of panic-like anxiety cases remain undiagnosed at the time of discharge from the emergency department. The 4-item Panic Screening Score questionnaire was derived in order to increase the identification of panic-like anxiety in emergency department patients with unexplained chest pain.
The goals of this prospective cohort study are to (1) refine the Panic Screening Score; (2) validate the revised version of the Panic Screening Score; (3) measure the reliability of the revised version of the Panic Screening Score and (4) assess the acceptability of the instrument among emergency physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No interventionEmergency department patients with unexplained chest pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the emergency department
Key inclusion criteria (5 listed)
- the absence of an identifiable cause (e.g., pneumothorax,pneumonia),
- the absence of chest trauma,
- the absence of new malignant cardiac arrhythmia, and
- a score of 2 or less on the modified version of the thrombolysis in myocardial infarction score.
Key exclusion criteria (4 listed)
- presence of a terminal illness;
- presence of a severe communication problem that could interfere with the administration of the questionnaire;
- presence of a psychotic state, a major cognitive deficit or other condition that could invalidate the interview;
- being legally incompetent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionValidation of the Panic Screening Score | Other | Patients |
Primary outcome
Accuracy of the Panic Screening Score
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Background: PubMed 24163208Foldes-Busque G, Denis I, Poitras J, Fleet RP, Archambault P, Dionne CE. A prospective cohort study to refine and validate the Panic Screening Score for identifying panic attacks associated with unexplained chest pain in the emergency department. BMJ Open. 2013 Oct 25;3(10):e003877. doi: 10.1136/bmjopen-2013-003877.
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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.
Guillaume Foldes-Busque, Ph.D principal investigator
Centre hospitalier affilié universitaire de Lévis
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 Noncardiac Chest Pain and Panic Attack, run by CISSS de Chaudière-Appalaches at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Apr 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Foldes-Busque, Ph.D (418-835-7121 ext. 1519, guillaume.Foldes-Busque@psy.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Panic Screening Score (time frame: 3 years). 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 NCT02405052, 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 1 Apr 2015.