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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 8, 2008
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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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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