Cohort of STEMI Patients

Myocardial Infarction Clinical Trial

— STEMI  

Official title:

CoHort of STEMI Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822638
• Other study ID #: 69HCL16_0412
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: June 30, 2016
• Start date: August 2009
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1204
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• STEMI PATIENT Cohort
PCI

Locations

Country	Name	City	State
France	Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Troponin	Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)	Day 0	No
Primary	Change in Creatine Kinase	Dosage of Creatine Kinase at hospital admission and 4 hours after PCI	Day 0	No
Secondary	New York Heart Association (NYHA) Class		at admission (Day 0)	No
Secondary	Left ventricular ejection fraction (LVEF)	LVEF measured by echocardiography	24 hours after PCI (Day 1)	No