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Sponsors and Collaborators: |
Singapore General Hospital National Medical Research Council (NMRC), Singapore National Heart Centre, Singapore |
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Information provided by: | Singapore General Hospital |
ClinicalTrials.gov Identifier: | NCT00434564 |
Objective
To compare the incidence of adverse cardiac events among the patients discharged after evaluation through ACTION protocol with those through conventional protocol. The adverse cardiac events for the follow-up are defined as any of the followings:
Design
Participants
Intervention
Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and blood will be drawn at 0,3,6 hours after arrival at ED for serial myoglobin, creatine kinase MB isoenzyme (CKMB) and Troponin T (TnT) . Patients who have ECG and blood test consistent with myocardial necrosis were admitted to the CCU. A senior doctor in the ED reviewed patients who were not admitted after 6 hours of observation.
Study Group
A stress tetrofosmin nuclear scan was done . Patients were then admitted and discharged depending on the results of the stress tetrofosmin scan.
Control group (conventional protocol)
Patients were then be admitted or discharged at the discretion of the senior ED doctor.
Measurement Patients were followed up at 1 week , 2 weeks , one month and six months for any adverse cardiac events such as cardiac related death , ventricular fibrillation , and myocardial infarction.
Statistical analysis Logistic regression analysis were used to compare the proportion of adverse events in the two treatment groups.
Condition | Intervention | Phase |
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Chest Pain |
Procedure: Stress nuclear scan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Trial on Early Stress Nuclear Scan for Patients Presented to the Emergency Department (ED) With Chest Pain But Non-Diagnostic Electrocardiography-Acute Chest Pain Treatment and Evaluation (ACTION) Study |
Estimated Enrollment: | 1690 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | May 2002 |
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Singapore | |
Singapore General Hospital | |
Singapore, Singapore |
Principal Investigator: | Lim S Han, MBBS, FRCS | Department of Emergency Medicine, Singapore General Hospital |
Study ID Numbers: | NMRC/0517/2001 |
Study First Received: | February 12, 2007 |
Last Updated: | February 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00434564 History of Changes |
Health Authority: | Singapore: Health Sciences Authority |
Stress nuclear scan Acute chest pain |
Signs and Symptoms Emergencies Stress Pain Chest Pain |
Signs and Symptoms Pain Chest Pain |