STEMI - ST Elevation Myocardial Infarction (MI)NCT06876974
Assessment of Prognosis and Myocardial Reperfusion in Patients with ST-segment-elevation Myocardial Infarction (STEMI) According to Coronary Atherosclerotic Burden.
An observational study of STEMI - ST Elevation Myocardial Infarction (MI), run by Central Hospital, Nancy, France.
Trial summary
In the current literature, it has been widely demonstrated that the extend of coronary atherosclerotic burden is associated with adverse long-term outcomes. Little is known about the impact of atheroma burden and either myocardial reperfusion and short-term outcomes after ST-segment elevation myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction (MI)
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023. STEMI was defined as follows: 1. continuous chest pain lasting at least 20 min 2. ST-segment elevation ≥1 mm in ≥2 contiguous leads on a 12-lead electrocardiogram or left bundle branch block and (3) treatment within 24 h of pain onset.
Who may be able to join
- patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023.
Who cannot join
- patients with missing or incomplete coronary angiogram.
About this study
In the current literature, it has been widely demonstrated that the extend of coronary atherosclerotic burden is associated with adverse long-term outcomes. Little is known about the impact of atheroma burden and either myocardial reperfusion and short-term outcomes after ST-segment elevation myocardial infarction (STEMI). Several angiographic scores have been used to measure the extend and severity of coronary atheroma. The SYNTAX score and the Gensini score have been shown to be independent predictors of cardiovascular events and mortality in stable coronary artery disease as well as in myocardial infarction.
This research therefore aims to assess the impact of overall coronary atherosclerotic burden, measured by two angiographic scores (SYNTAX score and Gensini score), both before and after primary percutaneous angioplasty, in patients with STEMI according to different clinical subgroups.
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
all-cause mortality at 45 days, 1 year and 2 years
Measured: 2 years
Recurrent acute coronary syndrome
Recurrent acute coronary syndrome at 1-year
Measured: 1 year
Secondary outcomes (2)
All-cause mortality in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
All-cause mortality at 45 days, 1 year and 2 years in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
Measured: 2 years
Recurrent acute coronary syndrome in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
Recurrent acute coronary syndrome at 1 year in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial Infarction (MI)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batric POPOVIC, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876974
- Sponsor's protocol ID
- 2025PI034
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prognosis and Myocardial Reperfusion in Patients with ST-segment-elevation Myocardial Infarction (STEMI) According to Coronary Atherosclerotic Burden.
- ClinicalTrials.gov ID
- NCT06876974
- Acronym / sponsor ID
- 2025PI034
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 14 Mar 2025 (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.
In the current literature, it has been widely demonstrated that the extend of coronary atherosclerotic burden is associated with adverse long-term outcomes. Little is known about the impact of atheroma burden and either myocardial reperfusion and short-term outcomes after ST-segment elevation myocardial infarction (STEMI). Several angiographic scores have been used to measure the extend and severity of coronary atheroma. The SYNTAX score and the Gensini score have been shown to be independent predictors of cardiovascular events and mortality in stable coronary artery disease as well as in myocardial infarction.
This research therefore aims to assess the impact of overall coronary atherosclerotic burden, measured by two angiographic scores (SYNTAX score and Gensini score), both before and after primary percutaneous angioplasty, in patients with STEMI according to different clinical subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023. STEMI was defined as follows: 1. continuous chest pain lasting at least 20 min 2. ST-segment elevation ≥1 mm in ≥2 contiguous leads on a 12-lead electrocardiogram or left bundle branch block and (3) treatment within 24 h of pain onset.
Key inclusion criteria (1 listed)
- patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023.
Key exclusion criteria (1 listed)
- patients with missing or incomplete coronary angiogram.
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
All-cause mortality
Time frame: 2 years
all-cause mortality at 45 days, 1 year and 2 years
Recurrent acute coronary syndrome
Time frame: 1 year
Recurrent acute coronary syndrome at 1-year
2 secondary outcomes
All-cause mortality in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
Time frame: 2 years
Recurrent acute coronary syndrome in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction (MI), run by Central Hospital, Nancy, 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: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
All-cause mortality (time frame: 2 years). The study lists 2 primary outcomes in all. 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 14 Mar 2025.