NCT05321667

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

March 26, 2022

Last Update Submit

April 4, 2022

Conditions

STEMI

Keywords

SMuRFsSMuRF-lessStandard Modifiable Risk FactorsPrognosisFamily History

Outcome Measures

Primary Outcomes (1)

  • MACE (Major Adverse Cardiovascular Event)

    Composite outcome including cardiovascular death or incidence of acute coronary syndrome, ischemic stroke or heart failure.

    3 years

Secondary Outcomes (4)

  • All-cause mortality

    3 years

  • Number of patients presenting cardiovascular death during the follow-up

    3 years

  • Number of patients presenting heart failure during the follow-up

    3 years

  • Number of patients presenting ischemic stroke during the follow-up

    3 years

Study Arms (2)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Systematic review of STEMI patients.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Coeur et des Vaisseaux Louis Mathieu

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Lucas SALVATI

CONTACT

+33620607540lu.k.salvati@gmail.com

Batric POPOVIC

CONTACT

b.popovic@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 11, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2022

Study Completion

August 31, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations

FR(1)