A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Other: blood samples

• Registration Number: NCT02608255
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

First objectives: demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Study Start: 2016-01
• Primary Completion: 2016-11
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acute coronary syndromes	blood samples	-

Primary Outcome Measures

Name	Time	Method
blood sample : dosage of CD26	12 MONTHS	demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.
blood sample: dosage of the copeptin	12 months
blood sample: dosage of troponin	12 months
blood sample : dosage of IMA	12 months	IMA (Albumin modified by the ischaemia)
blood sample: dosage of adenosin	12months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France