Myocardial Infarction, AcuteWAMIF-suiviNCT07181317
WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction: Cohort Follow up
An observational study of Myocardial Infarction, Acute, run by French Cardiology Society at 1 site in France.
Trial summary
The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Questionnaires and Major events
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to 30 Sep 2029
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: 314 women who had a myocardial infarction at less than 50 years, included in the WAMIF study conducted from 2017 to 2019 in 30 French research centers.
All patients who participated in the WAMIF study (research registration number with the French Ministry of Health : 2015-A01263-46 / Protocol registration with Clinical Trials NCT03073447) and wish to continue follow-up in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Pitié Salpétrière
Paris, 75012
Stéphane MANZO-SILBERMANN, MD
About this study
Official title: WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: Cohort Follow up
The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients.
Read the detailed description
The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. The main results were: a particularly high incidence of modifiable risk factors affecting 86% of patients, with smoking being the primary cause in 75% of them.The clinical presentation found chest pain in more than 90% of cases. The pathophysiological forms of acute coronary syndrome identified the culprit artery in 90% of cases, a form without obstruction (MINOCA) was found in 17.8% of ST segment elevation infarctions (STEMI), spontaneous dissection in 14.6% of STEMI and 16.3% of NSTEMI.At 12 months, follow-up showed no cardiovascular deaths and two deaths related to neoplastic causes. At the end of this follow-up, 90% had no events. Compared to existing studies, these event rates are extremely low. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients. The secondary objective is the evaluation of the quality of life and mental health of women who have had an MI before the age of 50 years at a distance from the acute event.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Questionnaires, Major events
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Assessment of stress and anxiety and quality of life after myocardial infarct:
- Stress score: Perceived Stress Scale-4 (PSS-4)
- Anxiety score: Generalized Anxiety Disorder-7 (GAD-7)
- Depression score: Patient Health Questionnaire-9 (PHQ-9)
- Quality of life scores: European Quality of Life-5 Dimensions (EQ-5D) and 12-Item Short-Form General Health Survey (SF-12)
Major eventsOther
Collection of information related to major events occurring since inclusion in the WAMIF study
| Study group | Role | What they receive |
|---|---|---|
| WAMIF patients | All patients who participated in the WAMIF study (NCT 03073447) and wish to continue follow-up in the present "WAMIF-suivi" study. Receives: Other: Questionnaires; Other: Major events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Number of patient who died from any cause since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Cardiovascular death
Number of patient who died from cardiovascular cause since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Stent thrombosis
Number of patient who had stent thrombosis since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Stroke
Number of patient who had stroke since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Recurrent myocardial infarct
Number of patient who had recurrent myocardial infarct since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Emergency revascularization
Number of patient who had emergency revascularization since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Major bleeding
Number of patient who had since major bleeding their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Emergency hospitalization for heart failure
Number of patient who had emergency hospitalization for heart failure since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Emergency department visit
Number of patient who went to emergency department since their participation in WAMIF study
Measured: 5 to 10 years after the participation in WAMIF study
Secondary outcomes (5)
Stress score
Perceived Stress Scale 4 items. It provides a total score (range 10-50, from worst to best) to assess the state of stress perceived by the patient
Measured: 5 to 10 years after the participation in WAMIF study
Anxiety score
Generalized Anxiety Disorder 7 items. It provides a total score to evaluate patient anxiety (range 0 to 21: 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety)
Measured: 5 to 10 years after the participation in WAMIF study
Depression score
Patient Health Questionnaire 9 items. It provides a total score (range 0-27, 1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; 20-27 severe depression) to diagnose and measure severity of depression.
Measured: 5 to 10 years after the participation in WAMIF study
Quality of life score
European Quality of Life 5 Dimensions. It provides a total score (range 0-100, from worst to the best) to evaluate the generic quality of life
Measured: 5 to 10 years after the participation in WAMIF study
Quality of life score
12 Item Short Form General Health Survey. It determines a respondent's profile in eight fields: physical function, physical role, physical pain, general health, vitality, social functioning, emotional role, and mental health
Measured: 5 to 10 years after the participation in WAMIF study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start25 Nov 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane MANZO SILBERMAN, MD, Principal investigator, Hôpital de la Pitié-Salpêtrière, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181317
- Sponsor's protocol ID
- 2025-04
- Acronym
- WAMIF-suivi
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WAMIF: Prospective Study in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: Cohort Follow up
- ClinicalTrials.gov ID
- NCT07181317
- Acronym / sponsor ID
- WAMIF-suivi / 2025-04
- Conditions
- Myocardial Infarction, Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Sep 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.
The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients.
Detailed description
The WAMIF study was conducted from 2017 to 2019, including 314 patients in 30 French research centers spread across metropolitan France. It systematically collected the clinical, morphological, and biological characteristics of myocardial infarction cases affecting women under 50 years of age and assessed their short-term (in-hospital) and medium-term (12-month) prognosis. The main results were: a particularly high incidence of modifiable risk factors affecting 86% of patients, with smoking being the primary cause in 75% of them.The clinical presentation found chest pain in more than 90% of cases. The pathophysiological forms of acute coronary syndrome identified the culprit artery in 90% of cases, a form without obstruction (MINOCA) was found in 17.8% of ST segment elevation infarctions (STEMI), spontaneous dissection in 14.6% of STEMI and 16.3% of NSTEMI.At 12 months, follow-up showed no cardiovascular deaths and two deaths related to neoplastic causes. At the end of this follow-up, 90% had no events. Compared to existing studies, these event rates are extremely low. Extending the follow-up beyond 12 months for this first study would provide fundamental data for understanding and improving the care of these patients. The secondary objective is the evaluation of the quality of life and mental health of women who have had an MI before the age of 50 years at a distance from the acute event.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WAMIF patients | – | Other: Questionnaires, Other: Major eventsAll patients who participated in the WAMIF study (NCT 03073447) and wish to continue follow-up in the present "WAMIF-suivi" study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 314 women who had a myocardial infarction at less than 50 years, included in the WAMIF study conducted from 2017 to 2019 in 30 French research centers.
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 |
|---|---|---|
| QuestionnairesAssessment of stress and anxiety and quality of life after myocardial infarct: * Stress score: Perceived Stress Scale-4 (PSS-4) * Anxiety score: Generalized Anxiety Disorder-7 (GAD-7) * Depression score: Patient Health Questionnaire-9 (PHQ-9) * Quality of life scores: European Quality of Life-5 Dimensions (EQ-5D) and 12-Item Short-Form General Health Survey (SF-12) | Other | WAMIF patients |
| Major eventsCollection of information related to major events occurring since inclusion in the WAMIF study | Other | WAMIF patients |
Primary outcome
Death from any cause
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who died from any cause since their participation in WAMIF study
Cardiovascular death
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who died from cardiovascular cause since their participation in WAMIF study
Stent thrombosis
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had stent thrombosis since their participation in WAMIF study
Stroke
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had stroke since their participation in WAMIF study
Recurrent myocardial infarct
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had recurrent myocardial infarct since their participation in WAMIF study
Emergency revascularization
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had emergency revascularization since their participation in WAMIF study
Major bleeding
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had since major bleeding their participation in WAMIF study
Emergency hospitalization for heart failure
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who had emergency hospitalization for heart failure since their participation in WAMIF study
Emergency department visit
Time frame: 5 to 10 years after the participation in WAMIF study
Number of patient who went to emergency department since their participation in WAMIF study
5 secondary outcomes
Stress score
Time frame: 5 to 10 years after the participation in WAMIF study
Anxiety score
Time frame: 5 to 10 years after the participation in WAMIF study
Depression score
Time frame: 5 to 10 years after the participation in WAMIF study
Quality of life score
Time frame: 5 to 10 years after the participation in WAMIF study
Quality of life score
Time frame: 5 to 10 years after the participation in WAMIF study
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 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Stéphane MANZO SILBERMAN, MD principal investigator
Hôpital de la Pitié-Salpêtrière, APHP
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, Acute, run by French Cardiology Society 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?
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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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?
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?
Contact Tessa BERGOT, MSc (+33144907033, tessa.bergot@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: 5 to 10 years after the participation in WAMIF study). The study lists 9 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 12 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.