Myocardial InfarctionSCANCT05159973
Patients With Non-ST-segment Elevation Acute Coronary Syndrome
An observational study of Myocardial Infarction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 21 Sep 2022
- 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 whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
Who may be able to join
- Adult patient (≥ 18 years old)
- Man or woman
- Patient admitted to the Emergency Department (SU) or to the Cardiology Department at the NHC between January 1, 2019 and December 31, 2020
- Patient whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
- Patient who did not express his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Frequency of Serious Rhythmic Complications in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is declining. Complications of MI, which include rhythm and conduction disturbances, are mainly associated with ACS ST +. It is recognized that these complications can occur during non-ST + ACS, but with less frequency. This frequency is not clearly established, and has been the subject of few studies. Recent studies in this direction suggest that the frequency of rhythmic complications is low during non-ST + ACS. However, the data collected concerns inter-hospital transport.
The aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-ST + ACS.
- Conditions
- Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, ACS, ST segment elevation, Myocardial infarction
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the frequency of occurrence of potentially fatal rhythmic complications in patients with non-ST segment elevation acute coronary syndrome
Measured: Files analysed retrospectively from January 01, 2019 to December 31, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Oct 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien HARSCOAT, MD, Principal investigator, Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159973
- Sponsor's protocol ID
- 8410
- Acronym
- SCA
- Status last verified
- Mar 2025
- First submitted
- 17 Nov 2021
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Serious Rhythmic Complications in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05159973
- Acronym / sponsor ID
- SCA / 8410
- Conditions
- Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, ACS, ST segment elevation, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 16 Dec 2021 (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.
There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is declining. Complications of MI, which include rhythm and conduction disturbances, are mainly associated with ACS ST +. It is recognized that these complications can occur during non-ST + ACS, but with less frequency. This frequency is not clearly established, and has been the subject of few studies. Recent studies in this direction suggest that the frequency of rhythmic complications is low during non-ST + ACS. However, the data collected concerns inter-hospital transport.
The aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-ST + ACS.
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 whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
Key inclusion criteria (5 listed)
- Adult patient (≥ 18 years old)
- Man or woman
- Patient admitted to the Emergency Department (SU) or to the Cardiology Department at the NHC between January 1, 2019 and December 31, 2020
- Patient whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
- Patient who did not express his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (2 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship, curatorship or safeguard of justice
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
Evaluation of the frequency of occurrence of potentially fatal rhythmic complications in patients with non-ST segment elevation acute coronary syndrome
Time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2020 will be examined]
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 6 Mar 2025.
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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.
Sébastien HARSCOAT, MD principal investigator
Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg
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 Myocardial Infarction, 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 5 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 6 Mar 2025. 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?
Evaluation of the frequency of occurrence of potentially fatal rhythmic complications in patients with non-ST segment elevation acute coronary syndrome (time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2020 will be examined]). 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 6 Mar 2025.