- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02822638
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Bron, Frankrig, 69677
- Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
STEMI PATIENT Cohort
|
PCI
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Troponin
Tidsramme: Day 0
|
Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI)
|
Day 0
|
|
Change in Creatine Kinase
Tidsramme: Day 0
|
Dosage of Creatine Kinase at hospital admission and 4 hours after PCI
|
Day 0
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
New York Heart Association (NYHA) Class
Tidsramme: at admission (Day 0)
|
at admission (Day 0)
|
|
|
Left ventricular ejection fraction (LVEF)
Tidsramme: 24 hours after PCI (Day 1)
|
LVEF measured by echocardiography
|
24 hours after PCI (Day 1)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michel OVIZE, Pr, Centre d'investigation Clinique , Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine - 69677 BRON
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69HCL16_0412
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