Clinical trial NCT04058782: Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
Official title: Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Vascular Stiffness
Heart Failure
Keywords: Prognosis
Vascular stiffness
Heart failure
Myocardial infarction
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fédération Française de Cardiologie
name: Merck Sharp & Dohme LLC
First posted: 2019-08-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry.

Over a 5-year period of time from 2019 to 2024. Planned population of 2000 patients. Follow-up every year by visit or phone contact up to 5 years.

Brief summary: Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Affiliated to national health insurance (French social security number)
* Presenting with MI within 48 hours of symptom onset

Exclusion Criteria:

* Patient under curatorship
* Type 2 MI
* Presenting with MI after 48 hours of symptom onset
* Pregnancy or lactating
* Refuse to participate
* No national health insurance (No French social security number)

Primary outcomes:
measure: MACE: Major adverse cardiovascular events
timeFrame: at 5 years
Secondary outcomes:
measure: Cardiovascular death
timeFrame: at 5 years
measure: Myocardial infarction
timeFrame: at 5 years
measure: Ischemic stroke
timeFrame: at 5 years
measure: Systemic embolism
timeFrame: at 5 years
measure: Acute limb ischemia
timeFrame: at 5 years
measure: Coronary revascularization
timeFrame: at 5 years
measure: Hospitalization for heart failure
timeFrame: at 5 years
measure: All-cause death
timeFrame: at 5 years
measure: Bleeding as assessed by Bleeding Academic Research Consortium (BARC)
timeFrame: at 5 years
measure: Bleeding as assessed by GUSTO Bleeding Criteria
timeFrame: at 5 years
measure: Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: at 5 years
measure: Bleeding as assessed by ISTH definitions
timeFrame: at 5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Coeur-Poumon, CHU
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lemesle, MD
role: PRINCIPAL_INVESTIGATOR
References: