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OpenTrials
Completed

NCT Number: NCT02608255

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 18, 2015
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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