Cohort of STEMI Patients (STEMI)

CoHort of STEMI Patients

Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.

However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.

Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.

In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ….

This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.

The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: STEMI PATIENT Cohort

• Study Type: Observational
• Enrollment (Actual): 1204

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine

Participation Criteria

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

STEMI PATIENT

Description

Inclusion Criteria:

• Age> 18 years
• Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
• Primary PCI within 12 hours of symptoms onset.

Exclusion Criteria:

• Diagnosis of STEMI not confirmed by angiography
• Refusal to participate in the study or to sign the consent
• Inability to give information to the subject about the study
• Lack of medical social coverage
• Deprivation of civil rights

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI PATIENT Cohort	Other: STEMI PATIENT Cohort; PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Troponin	Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)	Day 0
Change in Creatine Kinase	Dosage of Creatine Kinase at hospital admission and 4 hours after PCI	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association (NYHA) Class		at admission (Day 0)
Left ventricular ejection fraction (LVEF)	LVEF measured by echocardiography	24 hours after PCI (Day 1)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Michel OVIZE, Pr, Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: biomarkers; STEMI; Myocardial infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 69HCL16_0412