Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
Primary Purpose
Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological analysis of biomarkers
Biological analysis of biomarkers
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
- subjects over 18 years,
- subject about having a chest pain of coronary syndrome,
- subject about not having received heparin or LMWH
Exclusion Criteria:
- subject minor
- subject without informed consent,
- subject after receiving an anticoagulant treatment,
- transplanted heart, kidney or liver
Sites / Locations
- Hôpital de la Timone- Service cardiologie A
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Patients with coronary syndrome
Subjects without coronary syndrome
Outcomes
Primary Outcome Measures
To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).
Secondary Outcome Measures
Compare the characteristics of biological markers to those of usual or innovative markers
Full Information
NCT ID
NCT00769574
First Posted
October 8, 2008
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00769574
Brief Title
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
Official Title
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (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
To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients with coronary syndrome
Arm Title
2
Arm Type
Other
Arm Description
Subjects without coronary syndrome
Intervention Type
Other
Intervention Name(s)
Biological analysis of biomarkers
Intervention Description
Biological analysis of biomarkers
Intervention Type
Other
Intervention Name(s)
Biological analysis of biomarkers
Intervention Description
Biological analysis of biomarkers
Primary Outcome Measure Information:
Title
To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Compare the characteristics of biological markers to those of usual or innovative markers
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects over 18 years,
subject about having a chest pain of coronary syndrome,
subject about not having received heparin or LMWH
Exclusion Criteria:
subject minor
subject without informed consent,
subject after receiving an anticoagulant treatment,
transplanted heart, kidney or liver
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis BONNET, MD
Organizational Affiliation
Assistance Publique des Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Timone- Service cardiologie A
City
Marseille
ZIP/Postal Code
13385
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
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