Clinical trial NCT02226523: Magnetic Nanoparticles System in Acute Coronary Syndrome
Official title: The Development and Clinical Application of Rapid Assays Using Multi-antibody-activated Magnetic Nanoparticles System in Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: immunomagnetic reduction
acute coronary syndrome
serum biomarkers
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2014-08-27
Enrollment: 455
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute chest pain who are sent to the emergency departments will be included

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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis with acute coronary syndrome

Exclusion Criteria: none

Primary outcomes:
measure: Diagnositic accuracy of acute myocardial infarction
timeFrame: 7 days
Secondary outcomes:
measure: Combination of potential biomarkers in detection of ACS by rapid IMR system
timeFrame: 7 days
Other outcomes:
measure: Prediction of MACEs by rapid IMR system
timeFrame: 6 months
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yen-Wen Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: