Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

STEMI Clinical Trial

Official title:

Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05321667
• Other study ID #: 2021PI154
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2022
• Source: Central Hospital, Nancy, France
• Contact: Lucas SALVATI
• Phone: +33620607540
• Email: lu.k.salvati[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.

Exclusion Criteria:

Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Locations

Country	Name	City	State
France	Institut du Coeur et des Vaisseaux Louis Mathieu	Vandœuvre-lès-Nancy	Meurthe-et-Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (Major Adverse Cardiovascular Event)	Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure.	3 years
Secondary	All-cause mortality		3 years
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	Number of patients presenting ischemic stroke during the follow-up	Number of patients presenting fatal or non fatal ischemic stroke during the follow-up	3 years