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

NCT02608255 | Completed

• 1 other identifier: 2015-A01378-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (5)

• blood sample : dosage of CD26

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

  12 MONTHS

• blood sample: dosage of the copeptin

  12 months

• blood sample: dosage of troponin

  12 months

• blood sample : dosage of IMA

  IMA (Albumin modified by the ischaemia)

  12 months

• blood sample: dosage of adenosin

  12months

Study Arms (1)

acute coronary syndromes

EXPERIMENTAL

Other: blood samples

Interventions

blood samples OTHER

acute coronary syndromes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Withdrawing consent under study

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• BONELLO laurent

  AP HM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 18, 2015
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

FR (1)