<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02226523</url>
  </required_header>
  <id_info>
    <org_study_id>103002_N_103CT1026</org_study_id>
    <nct_id>NCT02226523</nct_id>
  </id_info>
  <brief_title>Magnetic Nanoparticles System in Acute Coronary Syndrome</brief_title>
  <official_title>The Development and Clinical Application of Rapid Assays Using Multi-antibody-activated Magnetic Nanoparticles System in Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To improve the sensitivity and specificity of immunoassay, the developing trends are to lower&#xD;
      the detection threshold and to minimize the cross reaction. A new assay technology called&#xD;
      immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small&#xD;
      volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and&#xD;
      operational priority in busy emergency departments (ED), early and correct diagnosis is&#xD;
      important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and&#xD;
      electrocardiography (ECG) in combination with the medical history and physical examination&#xD;
      are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good&#xD;
      diagnosis accuracy and have additional prognostic information are highly needed. The&#xD;
      combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque&#xD;
      ruptures or heart failure with different mechanism) may increase clinical sensitivity and&#xD;
      improve early risk stratification. The present study, a rapid IMR assay with multiple&#xD;
      biomarkers is proposed and we will examine the performance of this new investigational IMR&#xD;
      assays, comparison with current commercial assays.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To improve the sensitivity and specificity of immunoassay, the developing trends are to lower&#xD;
      the detection threshold and to minimize the cross reaction. A new assay technology called&#xD;
      immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with very small&#xD;
      volume of sample (i.e. less than 1ml whole blood). The reagent is a solution of homogeneously&#xD;
      dispersed magnetic nanoparticles, which are coated with hydrophilic surfactants and&#xD;
      bioprobes. Under external multiple alternating-current (ac) magnetic fields, magnetic&#xD;
      nanoparticles oscillate with the multiple ac magnetic fields via magnetic interaction. The&#xD;
      reagents under the external multiple ac magnetic fields show a magnetic property, called&#xD;
      mixed-frequency ac magnetic susceptibility χac. Magnetic nanoparticles bind with the&#xD;
      bioprobes on the outmost shell and become larger or clustered. The χac of the reagent is&#xD;
      reduced, and the concentration of the biomolecules can be measured quantitatively. Several&#xD;
      papers have demonstrated that IMR can be applied to assay proteins, viruses, chemicals, and&#xD;
      nucleic acids once suitable bioprobes are immobilized onto the magnetic nanoparticles.&#xD;
&#xD;
      Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and operational priority in&#xD;
      busy emergency departments (ED). Since ACS is associated with a significant mortality and&#xD;
      morbidity, early and correct diagnosis is of great importance. Chest pain is a frequent&#xD;
      symptom in medical emergency departments and distinguishing patients with ACS within the&#xD;
      chest pain group is a diagnostic challenge. Cardiac enzymes (including CPK/CK-MB, troponins,&#xD;
      myoglobulin) and electrocardiography (ECG) in combination with the medical history and&#xD;
      physical examination are at present the diagnostic cornerstones. Different cardiac enzymes&#xD;
      are released after myocardial cell disintegration and are markers of cell necrosis, which&#xD;
      might not be detected immediately after chest pain; and repeated measurements are suggested.&#xD;
      Therefore novel biomarkers that rise earlier, have good diagnosis accuracy and have&#xD;
      additional prognostic information are highly needed. Some publications address the potential&#xD;
      benefit of the combination of multiple biomarker assays (markers of myocardial injury,&#xD;
      inflammation/plaque ruptures or heart failure with different mechanism) could substantially&#xD;
      increase clinical sensitivity and improve early risk stratification. However, this approach&#xD;
      is rather time-consuming and not cost-effect. In the present study, a rapid IMR assay with&#xD;
      multiple biomarkers is proposed and we will examine the performance of this new&#xD;
      investigational IMR assays, comparison with current commercial assays.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Diagnositic accuracy of acute myocardial infarction</measure>
    <time_frame>7 days</time_frame>
    <description>Evaluation of the diagnostic performance of rapid IMR assays in detection of acute myocardial infarction; Cardiac enzymes (CPK/CK-MB, troponins), electrocardiography in combination with the symptoms of typical chest pain are at present the diagnostic gold standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combination of potential biomarkers in detection of ACS by rapid IMR system</measure>
    <time_frame>7 days</time_frame>
    <description>Compared to cardiac enzymes (CK/CK-MB, troponin), the diagnostic performance of combination of new biomarkers (BNP, FABP4, CRP, etc.) in detection of ACS by rapid IMR system</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prediction of MACEs by rapid IMR system</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of prognostic significance of multi-antibody-activated magnetic nanoparticles system (troponin, CK-MB, myoglobin, BNP, CRP, adipocyte fatty-acid binding protein/FABP-4) in acute coronary syndrome</description>
  </other_outcome>
  <enrollment type="Actual">455</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma/serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute chest pain who are sent to the emergency departments will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with acute coronary syndrome&#xD;
&#xD;
        Exclusion Criteria: none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yen-Wen Wu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Far Eastern Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taoyuan General Hospital, Ministry of Health and Welfare</name>
      <address>
        <city>Taoyuan</city>
        <zip>33004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 5, 2022</last_update_submitted>
  <last_update_submitted_qc>September 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Yen-Wen Wu</investigator_full_name>
    <investigator_title>Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine</investigator_title>
  </responsible_party>
  <keyword>immunomagnetic reduction</keyword>
  <keyword>acute coronary syndrome</keyword>
  <keyword>serum biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226523
org study id: 103002_N_103CT1026
nct id: NCT02226523
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To improve the sensitivity and specificity of immunoassay, the developing trends are to lower
      the detection threshold and to minimize the cross reaction. A new assay technology called
      immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small
      volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and
      operational priority in busy emergency departments (ED), early and correct diagnosis is
      important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and
      electrocardiography (ECG) in combination with the medical history and physical examination
      are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good
      diagnosis accuracy and have additional prognostic information are highly needed. The
      combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque
      ruptures or heart failure with different mechanism) may increase clinical sensitivity and
      improve early risk stratification. The present study, a rapid IMR assay with multiple
      biomarkers is proposed and we will examine the performance of this new investigational IMR
      assays, comparison with current commercial assays.
To improve the sensitivity and specificity of immunoassay, the developing trends are to lower
      the detection threshold and to minimize the cross reaction. A new assay technology called
      immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with very small
      volume of sample (i.e. less than 1ml whole blood). The reagent is a solution of homogeneously
      dispersed magnetic nanoparticles, which are coated with hydrophilic surfactants and
      bioprobes. Under external multiple alternating-current (ac) magnetic fields, magnetic
      nanoparticles oscillate with the multiple ac magnetic fields via magnetic interaction. The
      reagents under the external multiple ac magnetic fields show a magnetic property, called
      mixed-frequency ac magnetic susceptibility χac. Magnetic nanoparticles bind with the
      bioprobes on the outmost shell and become larger or clustered. The χac of the reagent is
      reduced, and the concentration of the biomolecules can be measured quantitatively. Several
      papers have demonstrated that IMR can be applied to assay proteins, viruses, chemicals, and
      nucleic acids once suitable bioprobes are immobilized onto the magnetic nanoparticles.

      Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and operational priority in
      busy emergency departments (ED). Since ACS is associated with a significant mortality and
      morbidity, early and correct diagnosis is of great importance. Chest pain is a frequent
      symptom in medical emergency departments and distinguishing patients with ACS within the
      chest pain group is a diagnostic challenge. Cardiac enzymes (including CPK/CK-MB, troponins,
      myoglobulin) and electrocardiography (ECG) in combination with the medical history and
      physical examination are at present the diagnostic cornerstones. Different cardiac enzymes
      are released after myocardial cell disintegration and are markers of cell necrosis, which
      might not be detected immediately after chest pain; and repeated measurements are suggested.
      Therefore novel biomarkers that rise earlier, have good diagnosis accuracy and have
      additional prognostic information are highly needed. Some publications address the potential
      benefit of the combination of multiple biomarker assays (markers of myocardial injury,
      inflammation/plaque ruptures or heart failure with different mechanism) could substantially
      increase clinical sensitivity and improve early risk stratification. However, this approach
      is rather time-consuming and not cost-effect. In the present study, a rapid IMR assay with
      multiple biomarkers is proposed and we will examine the performance of this new
      investigational IMR assays, comparison with current commercial assays.
observational model: Cohort
time perspective: Prospective
measure: Diagnositic accuracy of acute myocardial infarction
time frame: 7 days
description: Evaluation of the diagnostic performance of rapid IMR assays in detection of acute myocardial infarction; Cardiac enzymes (CPK/CK-MB, troponins), electrocardiography in combination with the symptoms of typical chest pain are at present the diagnostic gold standard.
measure: Combination of potential biomarkers in detection of ACS by rapid IMR system
time frame: 7 days
description: Compared to cardiac enzymes (CK/CK-MB, troponin), the diagnostic performance of combination of new biomarkers (BNP, FABP4, CRP, etc.) in detection of ACS by rapid IMR system
measure: Prediction of MACEs by rapid IMR system
time frame: 6 months
description: Evaluation of prognostic significance of multi-antibody-activated magnetic nanoparticles system (troponin, CK-MB, myoglobin, BNP, CRP, adipocyte fatty-acid binding protein/FABP-4) in acute coronary syndrome
plasma/serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yen-Wen Wu, MD, PhD
role: Principal Investigator
affiliation: Far Eastern Memorial Hospital
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Yen-Wen Wu
investigator title: Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No