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

April 4, 2022 updated by: Batric POPOVIC, Central Hospital, Nancy, France
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • Institut du Coeur et des Vaisseaux Louis Mathieu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Systematic review of STEMI patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 years
3 years
Number of patients presenting cardiovascular death during the follow-up
Time Frame: 3 years
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
Number of patients presenting heart failure during the follow-up
Time Frame: 3 years
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
Number of patients presenting ischemic stroke during the follow-up
Time Frame: 3 years
Number of patients presenting fatal or non fatal ischemic stroke during the follow-up
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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