STEMINCT05321667
Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)
An observational study of STEMI, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Systematic review of STEMI patients.
Who may be able to join
- STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.
Who cannot join
- Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.
Trial locations and contacts
1 site in 1 country.
Batric POPOVIC contact
France1 site
Institut du Coeur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500
Lucas SALVATI, +33620607540, lu.k.salvati@gmail.com
About this study
The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.
- Conditions
- STEMI
- Keywords
- SMuRFs, SMuRF-less, Standard Modifiable Risk Factors, Prognosis, Family History
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SMuRF-less | Patients presenting no standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). | |
| SMuRFs | Patients presenting at least one standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Adverse Cardiovascular Event)
Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure.
Measured: 3 years
Secondary outcomes (4)
All-cause mortality
Measured: 3 years
Number of patients presenting cardiovascular death during the follow-up
Number of patients presenting death due to fatal myocardial infarction, fatal ischemic stroke, sudden death, severe heart failure and cardiogenic shock during the follow-up.
Measured: 3 years
Number of patients presenting heart failure during the follow-up
Number of patients hospitalized for acute heart failure during the follow-up, as well as patients presenting persistent symptoms of chronic heart failure after their STEMI (dyspnea NYHA > 1) and/or long-terme need for diuretics.
Measured: 3 years
Number of patients presenting ischemic stroke during the follow-up
Number of patients presenting fatal or non fatal ischemic stroke during the follow-up
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 posted11 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- 500 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
- NCT05321667
- Sponsor's protocol ID
- 2021PI154
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)
- ClinicalTrials.gov ID
- NCT05321667
- Acronym / sponsor ID
- 2021PI154
- Conditions
- STEMI
- Keywords
- SMuRFs, SMuRF-less, Standard Modifiable Risk Factors, Prognosis, Family History
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Apr 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.
The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMuRF-less | – | –Patients presenting no standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). |
| SMuRFs | – | –Patients presenting at least one standard modifiable risk factor of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension, and cigarette smoking). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systematic review of STEMI patients.
Key inclusion criteria (1 listed)
- STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.
Key exclusion criteria (1 listed)
- Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.
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
MACE (Major Adverse Cardiovascular Event)
Time frame: 3 years
Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure.
4 secondary outcomes
All-cause mortality
Time frame: 3 years
Number of patients presenting cardiovascular death during the follow-up
Time frame: 3 years
Number of patients presenting heart failure during the follow-up
Time frame: 3 years
Number of patients presenting ischemic stroke during the follow-up
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 11 Apr 2022.
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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.
Batric POPOVIC contact
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 STEMI, run by Central Hospital, Nancy, 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 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas SALVATI (+33620607540, lu.k.salvati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (Major Adverse Cardiovascular Event) (time frame: 3 years). 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 11 Apr 2022.