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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608255
• Other study ID #: 2015-A01378-41
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: January 3, 2017
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Ischemia

Intervention

Other:
• blood samples

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood sample : dosage of CD26	demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.	12 MONTHS	No
Primary	blood sample: dosage of the copeptin		12 months	No
Primary	blood sample: dosage of troponin		12 months	No
Primary	blood sample : dosage of IMA	IMA (Albumin modified by the ischaemia)	12 months	No
Primary	blood sample: dosage of adenosin		12months	No