Magnetic Nanoparticles System in Acute Coronary Syndrome

NCT02226523 | Completed

• 1 other identifier: 103002_N_103CT1026
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Coronary Syndrome

Keywords

immunomagnetic reduction; acute coronary syndrome; serum biomarkers

Outcome Measures

Primary Outcomes (1)

• Diagnositic accuracy of acute myocardial infarction

  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.

  7 days

Secondary Outcomes (1)

• Combination of potential biomarkers in detection of ACS by rapid IMR system

  7 days

Other Outcomes (1)

• Prediction of MACEs by rapid IMR system

  6 months

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute chest pain who are sent to the emergency departments will be included

You may qualify if:

• Diagnosis with acute coronary syndrome

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead
• National Taiwan University Hospital: collaborator

Study Sites (3)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, 33004, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma/serum

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yen-Wen Wu, MD, PhD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)