Magnetic Nanoparticles System in Acute Coronary Syndrome

NCT ID: NCT02226523

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 455 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2022-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Diagnosis with acute coronary syndrome

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Responsible Party

Yen-Wen Wu

Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yen-Wen Wu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Locations

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

103002_N_103CT1026

Identifier Type: -

Identifier Source: org_study_id