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Clinical Trials/NCT02822638
NCT02822638CompletedNot Applicable

CoHort of STEMI Patients

Hospices Civils de Lyon1 site in 1 country1,204 target enrollmentStarted: August 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,204
Locations
1
Primary Endpoint
Change in Troponin

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Troponin

Time Frame: Day 0

Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)

Change in Creatine Kinase

Time Frame: Day 0

Dosage of Creatine Kinase at hospital admission and 4 hours after PCI

Secondary Outcomes

  • Left ventricular ejection fraction (LVEF)(24 hours after PCI (Day 1))
  • New York Heart Association (NYHA) Class(at admission (Day 0))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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