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

NCT ID: NCT02608255

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

acute coronary syndromes

Group Type: EXPERIMENTAL

blood samples

Intervention Type: OTHER

Interventions

blood samples

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BONELLO laurent

Role: PRINCIPAL_INVESTIGATOR

AP HM

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2015-A01378-41

Identifier Type: -

Identifier Source: org_study_id