Acute Coronary SyndromeCalci-DTNCT05538117
Diagnostic Performance of Coronary Calcification Detection on CT Scan
An observational study of Acute Coronary Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
thoracic pain is one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. 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
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2022to 18 Oct 2023
- 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
- Adult, Older adult
Study population: Adult patient (≥18 years old) admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain <30min or atypical symptoms but non-eliminable cardiac origin.
Who may be able to join
- Adult patient (≥18 years old)
- Patient admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain <30min or atypical symptoms but non-eliminable cardiac origin.
- Patient with an initial assessment within the norms (ECG not modified, first troponin negative) and having performed a chest CT scan
- Patient who has not expressed his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'accueil des urgences - CHU de Strasbourg - France
Strasbourg, 67091
About this study
thoracic pain is one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. Efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management.
The investigators seek to evaluate whether a diagnostic strategy based on a thoracic CT scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Thoracic pain, Acute coronary event, CT scan, Thoracic scan, Coronary calcifications, Acute Coronary Syndrome
- 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.
Ability of scan CT to detect coronary calcifications in patients presenting with thoracic pain to the emergency department
Presence on the scanner of calcifications 30 minutes after onset of pain
Measured: 30 minutes after onset of pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start18 Aug 2022
- Primary completion18 Aug 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538117
- Sponsor's protocol ID
- 8697
- Acronym
- Calci-DT
- Status last verified
- Dec 2023
- First submitted
- 8 Sep 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Coronary Calcification Detection on CT Scan
- ClinicalTrials.gov ID
- NCT05538117
- Acronym / sponsor ID
- Calci-DT / 8697
- Conditions
- Acute Coronary Syndrome
- Keywords
- Thoracic pain, Acute coronary event, CT scan, Thoracic scan, Coronary calcifications, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- 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 one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. Efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management.
The investigators seek to evaluate whether a diagnostic strategy based on a thoracic CT scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain <30min or atypical symptoms but non-eliminable cardiac origin.
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- Patient admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain <30min or atypical symptoms but non-eliminable cardiac origin.
- Patient with an initial assessment within the norms (ECG not modified, first troponin negative) and having performed a chest CT scan
- Patient who has not expressed his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (1 listed)
- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes
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
Ability of scan CT to detect coronary calcifications in patients presenting with thoracic pain to the emergency department
Time frame: 30 minutes after onset of pain
Presence on the scanner of calcifications 30 minutes after onset of pain
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 13 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Coronary Syndrome, run by University Hospital, Strasbourg, France 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 4 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 13 Dec 2023. 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?
Ability of scan CT to detect coronary calcifications in patients presenting with thoracic pain to the emergency department (time frame: 30 minutes after onset of pain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.