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The Role of Netrin -1 in Acute Coronary Syndrome (ACS-NETRİN-1)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
netrin-1 value on admission to hospital
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring netrin-1, acs, reperfuzion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients over the age of 18
  • diagnose ACS
  • patients undergoing angiography

Exclusion Criteria:

  • CVE history
  • Neurological disease
  • Pregnancy and Lactation
  • Liver failure
  • Diagnosed malignity
  • Use of anticonvulsant and nephrotoxic medication
  • Chronic kidney disease
  • Not having angiography
  • Developing acute renal failure after angiography
  • Patients who rejected to participate were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ACS GRUP

    plasebo grup

    Arm Description

    Demographic characteristics, history, vital signs, laboratory findings, coronary angiography (CAG) and echocardiography (ECO) findings of the patients were recorded. Netrin-1 levels were studied with blood collected at the hospital and 6-8 hours after CAG. CAG results were evaluated by TIMI flow. The patients were divided into two groups with and without TIMI 3 flow and Netrin-1 levels were compared. GRACE (Global Registry of Acute Coronary Events) and TIMI (Thrombolysis in Myocardial Ischemia) clinical risk assessments were performed and Netrin-1 values were compared.

    It consisted of those without any disease and netri-1 values at admission were compared with the uptake patient group.

    Outcomes

    Primary Outcome Measures

    serum netrin-1 value
    Netrin-1 in plasma was measured by enzyme-linked immunosorbent assay (ELISA) (Mybıosource MBS044526 ) All assays were performed in duplicate. Plasma Netrin-1 is expressed in picograms (pg) per mg.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2019
    Last Updated
    July 18, 2019
    Sponsor
    Aksaray University Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04027127
    Brief Title
    The Role of Netrin -1 in Acute Coronary Syndrome
    Acronym
    ACS-NETRİN-1
    Official Title
    The Effect of Serum Netrin-1 Levels on Diagnosis and Prognosis in Patients Presenting to the Emergency Department With Acute Coronary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2013 (Actual)
    Primary Completion Date
    August 15, 2014 (Actual)
    Study Completion Date
    June 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aksaray University Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In our study, Netrin -1; We found that patients with ACS increased at the time of admission, decreased TIMI 3 flow after angiography, and higher risk groups in high risk groups such as TIMI and GRACE were found to have higher Netrin-1 levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome
    Keywords
    netrin-1, acs, reperfuzion

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    PATIENT AND CONTROL GROUP will be divided into two.
    Masking
    Participant
    Masking Description
    Patient group; Those diagnosed with ACS over 18 years of age, planned angiography and accepted angiography. The control group consisted of volunteers without disease.
    Allocation
    Non-Randomized
    Enrollment
    238 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ACS GRUP
    Arm Type
    Active Comparator
    Arm Description
    Demographic characteristics, history, vital signs, laboratory findings, coronary angiography (CAG) and echocardiography (ECO) findings of the patients were recorded. Netrin-1 levels were studied with blood collected at the hospital and 6-8 hours after CAG. CAG results were evaluated by TIMI flow. The patients were divided into two groups with and without TIMI 3 flow and Netrin-1 levels were compared. GRACE (Global Registry of Acute Coronary Events) and TIMI (Thrombolysis in Myocardial Ischemia) clinical risk assessments were performed and Netrin-1 values were compared.
    Arm Title
    plasebo grup
    Arm Type
    Active Comparator
    Arm Description
    It consisted of those without any disease and netri-1 values at admission were compared with the uptake patient group.
    Intervention Type
    Other
    Intervention Name(s)
    netrin-1 value on admission to hospital
    Primary Outcome Measure Information:
    Title
    serum netrin-1 value
    Description
    Netrin-1 in plasma was measured by enzyme-linked immunosorbent assay (ELISA) (Mybıosource MBS044526 ) All assays were performed in duplicate. Plasma Netrin-1 is expressed in picograms (pg) per mg.
    Time Frame
    30 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients over the age of 18 diagnose ACS patients undergoing angiography Exclusion Criteria: CVE history Neurological disease Pregnancy and Lactation Liver failure Diagnosed malignity Use of anticonvulsant and nephrotoxic medication Chronic kidney disease Not having angiography Developing acute renal failure after angiography Patients who rejected to participate were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hüseyin Mutlu, MD
    Organizational Affiliation
    Aksaray/Turkey
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Role of Netrin -1 in Acute Coronary Syndrome

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