Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetic Nanoparticles System in Acute Coronary Syndrome

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: NCT02226523
Recruitment Status : Unknown
Verified February 2018 by Yen-Wen Wu, Far Eastern Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Yen-Wen Wu, Far Eastern Memorial Hospital

Brief Summary:
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.

Condition or disease
Acute Coronary Syndrome

Detailed Description:

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 649 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Development and Clinical Application of Rapid Assays Using Multi-antibody-activated Magnetic Nanoparticles System in Acute Coronary Syndrome
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort
ACS
subjects with final diagnosis of ACS, or non-ACS



Primary Outcome Measures :
  1. Diagnositic accuracy of acute myocardial infarction [ Time Frame: 7 days ]
    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.


Secondary Outcome Measures :
  1. Combination of potential biomarkers in detection of ACS by rapid IMR system [ Time Frame: 7 days ]
    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


Other Outcome Measures:
  1. Prediction of MACEs by rapid IMR system [ Time Frame: 6 months ]
    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


Biospecimen Retention:   Samples Without DNA
plasma/serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute chest pain who are sent to the emergency departments will be included
Criteria

Inclusion Criteria:

  • Diagnosis with acute coronary syndrome

Exclusion Criteria: none


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): NCT02226523


Locations
Layout table for location information
Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
National Taiwan University Hospital
Taipei, Taiwan, 100
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan, 33004
Sponsors and Collaborators
Far Eastern Memorial Hospital
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yen-Wen Wu, MD, PhD Far Eastern Memorial Hospital

Additional Information:

Layout table for additonal information
Responsible Party: Yen-Wen Wu, Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02226523    
Other Study ID Numbers: 103002_N_103CT1026
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yen-Wen Wu, Far Eastern Memorial Hospital:
immunomagnetic reduction
acute coronary syndrome
serum biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases