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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608255
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: blood samples Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage
Study Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
Experimental: acute coronary syndromes Other: blood samples



Primary Outcome Measures :
  1. blood sample : dosage of CD26 [ Time Frame: 12 MONTHS ]
    demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.

  2. blood sample: dosage of the copeptin [ Time Frame: 12 months ]
  3. blood sample: dosage of troponin [ Time Frame: 12 months ]
  4. blood sample : dosage of IMA [ Time Frame: 12 months ]
    IMA (Albumin modified by the ischaemia)

  5. blood sample: dosage of adenosin [ Time Frame: 12months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608255


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: BONELLO laurent AP HM

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02608255    
Other Study ID Numbers: 2015-A01378-41
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Ischemia
Chest Pain
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms