Back to resultsA Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acute coronary syndromes
Arm Description
Outcomes
Primary Outcome Measures
blood sample : dosage of CD26
demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.
blood sample: dosage of the copeptin
blood sample: dosage of troponin
blood sample : dosage of IMA
IMA (Albumin modified by the ischaemia)
blood sample: dosage of adenosin
Secondary Outcome Measures
Full Information
NCT ID
NCT02608255
First Posted
November 10, 2015
Last Updated
January 3, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02608255
Brief Title
A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
Official Title
A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acute coronary syndromes
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood samples
Primary Outcome Measure Information:
Title
blood sample : dosage of CD26
Description
demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.
Time Frame
12 MONTHS
Title
blood sample: dosage of the copeptin
Time Frame
12 months
Title
blood sample: dosage of troponin
Time Frame
12 months
Title
blood sample : dosage of IMA
Description
IMA (Albumin modified by the ischaemia)
Time Frame
12 months
Title
blood sample: dosage of adenosin
Time Frame
12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BONELLO laurent
Organizational Affiliation
AP HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
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A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
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