- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02608255
A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.
All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Marseille, Frankrig, 13354
- Assistance Publique Hôpitaux de Marseille
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subject with compatible symptoms with an acute coronary syndrome, for at least 15 minutes and not older than 3 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or two arms, pain in the jaw, pain in the back / neck / stomach, breathlessness , cold sweats, nausea / vomiting , dizziness )
- Man or woman,
- Patient Did not receive heparin or low molecular weight heparin (LMWH ) before the initial blood sample ,
- Patient Agreeing to participate in the study and who signed an informed consent
Exclusion Criteria:
- Minor or major patient trust
- Patient Not having signed informed consent (refusal , physical or mental disability ... )
- Patient Who received anticoagulation before carrying blood samples
- Patient With a progressive septic processes , neoplasia undergoing treatment, dialyzed kidney failure, a history of surgery or coronary angioplasty less than six months.
- Transplanted heart, renal or hepatic
- heart attack
- Subject Whose symptoms clearly eliminates acute coronary syndrome ( penetrating trauma, traumatic injury by crushing ... )
- Patient Died between the time of inclusion and arrival in the cardiology intensive care ( SIC )
- Patient Withdrawing consent under study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: acute coronary syndromes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
blood sample : dosage of CD26
Tidsramme: 12 MONTHS
|
demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.
|
12 MONTHS
|
|
blood sample: dosage of the copeptin
Tidsramme: 12 months
|
12 months
|
|
|
blood sample: dosage of troponin
Tidsramme: 12 months
|
12 months
|
|
|
blood sample : dosage of IMA
Tidsramme: 12 months
|
IMA (Albumin modified by the ischaemia)
|
12 months
|
|
blood sample: dosage of adenosin
Tidsramme: 12months
|
12months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: BONELLO laurent, Ap Hm
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-A01378-41
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