Arrythmia -Myocardial InfarctionSTEMINCT05040919
Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
An observational study of Arrythmia -Myocardial Infarction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia -Myocardial Infarction
- What is being tested?
- collection of medical and socio-demographic data
- How many people
- 652 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2021to 30 Jun 2021
- 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: every adult patient with a STEMI in prehospital, manage by a physician and bring to the CHU of Dijon
Who may be able to join
- > 18 years old, with STEMI, in prehospital patient, take by a medecine, bring to the CHU Dijon
Who cannot join
- < 18 years old, without STEMI, no medical in prehospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.
We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia
- Conditions
- Arrythmia -Myocardial Infarction
- Being tested
- collection of medical and socio-demographic data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of medical and socio-demographic dataOther
collection of medical and socio-demographic data
| Study group | Role | What they receive |
|---|---|---|
| with an arrythmia | patient suffering from STEMI and presenting an arrythmia Receives: Other: collection of medical and socio-demographic data | |
| without an arrythmia | patient suffering from STEMI and not presenting an arrythmia Receives: Other: collection of medical and socio-demographic data |
What is being measured
The primary outcome is the main question the study is designed to answer.
arrhythmia
arrhythmia during acute STEMI
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start3 Mar 2021
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrythmia -Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Retrospective
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040919
- Sponsor's protocol ID
- TIMSIT - Gevrey 2021
- Acronym
- STEMI
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05040919
- Acronym / sponsor ID
- STEMI / TIMSIT - Gevrey 2021
- Conditions
- Arrythmia -Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Sep 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.
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.
We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with an arrythmia | – | Other: collection of medical and socio-demographic datapatient suffering from STEMI and presenting an arrythmia |
| without an arrythmia | – | Other: collection of medical and socio-demographic datapatient suffering from STEMI and not presenting an arrythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every adult patient with a STEMI in prehospital, manage by a physician and bring to the CHU of Dijon
Key inclusion criteria (1 listed)
- > 18 years old, with STEMI, in prehospital patient, take by a medecine, bring to the CHU Dijon
Key exclusion criteria (1 listed)
- < 18 years old, without STEMI, no medical in prehospital
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 |
|---|---|---|
| collection of medical and socio-demographic datacollection of medical and socio-demographic data | Other | with an arrythmia, without an arrythmia |
Primary outcome
arrhythmia
Time frame: at baseline
arrhythmia during acute STEMI
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 10 Sep 2021.
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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 Arrythmia -Myocardial Infarction, run by Centre Hospitalier Universitaire Dijon 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 1 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 10 Sep 2021. 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?
arrhythmia (time frame: at baseline). 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 10 Sep 2021.