Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434564
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2007-02-12
Brief Title:
Acute Chest Pain Treatment and Evaluation ACTION Study
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective
1 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
Cardiac related death
Ventricular fibrillation
Myocardial infarction
Cardiogenic shock requiring the inta-aortic balloon pump circulatory assistance
Acute pulmonary oedema requiring endo-tracheal intubation
2 To study the sensitivity predictive values of the various components of ACTION 12 lead ECG ST monitoring serial serum markers for myocardial necrosis myoglobin CKMB TnT graded exercise testing stress tetrofosmin scan stress echocardiography in predicting adverse cardiac events
Design -prospective randomised clinical trial
Participants
-patients above 25 years of age presenting to the ED with chest pain consistent with myocardial ischaemia but with a 12 lead ECG non-diagnostic of myocardial ischaemia
Intervention
Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and blood will be drawn at 036 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
1 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
Cardiac related death
Ventricular fibrillation
Myocardial infarction
Cardiogenic shock requiring the inta-aortic balloon pump circulatory assistance
Acute pulmonary oedema requiring endo-tracheal intubation
2 To study the sensitivity predictive values of the various components of ACTION 12 lead ECG ST monitoring serial serum markers for myocardial necrosis myoglobin CKMB TnT graded exercise testing stress tetrofosmin scan stress echocardiography in predicting adverse cardiac events
Design -prospective randomised clinical trial
Participants
-patients above 25 years of age presenting to the ED with chest pain consistent with myocardial ischaemia but with a 12 lead ECG non-diagnostic of myocardial ischaemia
Intervention
Patients were monitored continuously with a 12 lead ECG and ST segment trend monitoring and blood will be drawn at 036 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
Detailed Description:
Identifying the cause of chest pain is a challenge to the Emergency PhysicianCoronary artery disease is the most common group of Emergencies that has a high potential for rapidly developing a lethal outcome
Significant proportion of patients who presented to and released from the Emergency Department EDwith AMI or unstable angina develop poor outcomes This is because a large proportion of AMI present atypicallyThe initial single 12 lead ECG done at an ED is only 50 sensitive for AMISerial ECGs have been shown to improve sensitivity by 25Because of these limitations physicians may admit patients with chest pain liberally On the other hand only 25-50 of patients admitted to CCU without AMI are eventually determined to have Acute Coronary Syndrome
Several serum cardiac markers such as myoglobulin CKMB and Troponin T TnT are found to increase sensitivity in detecting AMI than just history and ECG Among them TnT is a better predictor of adverse cardiac event than CKMB Absence of TnT elevation identifies a lower risk group of patients but not necessarily a low risk group since TnT cannot detect myocardial ischaemia in the absence of myocardial injury or myocyte cell death
There has been some chest pain evaluation practice in the ED using the graded exercise testing to screen for severe ischaemia
Several studies have suggested the safety of exercise testing in low risk patients presenting to ED with chest painThe use of exercise testing has been found to be a powerful tool for prognostication
Stress nuclear imaging was also performed at the end of 6 hours of observation instead of graded exercise stress testing alone There will be a significant proportion of patients who will not be eligible for standard exercise treadmill stress test due to poor exercise tolerance Even for those who underwent exercise testing studies showed that 242 were inconclusive because of baseline ECG abnormalities left ventricular hypertrophy left bundle-branch block or patient on digoxin Some patients may not be able to achieve the required exercise level
Studies have shown that the mean sensitivity and specificity for graded exercise testing to detect severe coronary artery disease were 68 and 77 respectively The sensitivity of graded exercise test for detecting single vessel disease is lower
Stress nuclear imaging is valuable in establishing the prognosis of patients with a low likelihood of coronary artery disease Stress nuclear scans have additive prognostic value to graded exercise test especially if the latter is abnormal or non-diagnosticFor those who cannot exercise pharmacological stress tetrofosmin with dobutamine or adenosine will be performed instead
The efficacy of acute chest pain evaluation centre has not been compared with a conventional protocol in a prospective randomised clinical trial
Aims
1 To compare the incidence of adverse cardiac events among patients discharged after evaluation through ACTION with those through conventional protocol Adverse cardiac events are defined as any of the following
i Cardiac related death ii Ventricular fibrillation iii Myocardial infarction iv Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance v Acute pulmonary oedema requiring endotracheal intubation
2 To study the sensitivity specificity graded exercises testing stress tetrofosmin scan in predicting adverse cardiac event
5 Treatment Plan
First 6 hours Once informed consent was obtained the patient was then enrolled They were put on continuous ECG monitoring Ten mls of blood were drawn at 036 hours after arrival at the ED for myoglobin CKMB and TnT analysis Blood for LDL HDL were also drawn at 0 hour as well with the cardiac markers The old hospital case record of patient if available were retrieved and previous ECGs were also compared against the new ECG
Patients who develop recurring chest pain consistent with myocardial ischaemia ST segment elevation or depression on continuous 12 lead ECG monitoring indicating myocardial necrosis or have positive CKMB 5 Troponin T 001 were admitted to the Department of Cardiology If the patient was not admitted at the end of 6 hours heshe were reviewed by a ED RegistrarAssociate ConsultantConsultant The senior ED doctor reviewed the patient his her 12 lead ECGs and blood results for serum markers for myocardial necrosis
After first 6 hours - Study Group Intervention Protocol
The patient then underwent a stress tetrofosmin scan within 24 hours of presentation exercise or pharmacological stress for those who cannot exercise Tetrofosmin scans was be done at NHC or the Department of Nuclear Medicine SGH Patients were monitored until the test was completed If the stress tetrofosmin scan turned out to be positive the patient was then admitted to the hospital for further management If the stress tetrofosmin scan was negative the patient was released from ED with instructions for follow-up in the cardiology clinic as an outpatient
Control Group conventional protocol The patient with high or intermediate risk for coronary artery disease CAD as defined by Agency for HealthCare Policy and Research guidelines for Unstable Angina was admitted The indicators for coronary artery disease are definite angina T wave inversion 1 mm in leads with dominant R waves and diabetes If in doubt patients were also admitted Patients who were discharged from the ED will be reviewed by a cardiologist at the NHC cardiac clinic within two weeks
6 Follow Up
Patients were followed up at one month six months and one year for any primary or secondary endpoints
Significant proportion of patients who presented to and released from the Emergency Department EDwith AMI or unstable angina develop poor outcomes This is because a large proportion of AMI present atypicallyThe initial single 12 lead ECG done at an ED is only 50 sensitive for AMISerial ECGs have been shown to improve sensitivity by 25Because of these limitations physicians may admit patients with chest pain liberally On the other hand only 25-50 of patients admitted to CCU without AMI are eventually determined to have Acute Coronary Syndrome
Several serum cardiac markers such as myoglobulin CKMB and Troponin T TnT are found to increase sensitivity in detecting AMI than just history and ECG Among them TnT is a better predictor of adverse cardiac event than CKMB Absence of TnT elevation identifies a lower risk group of patients but not necessarily a low risk group since TnT cannot detect myocardial ischaemia in the absence of myocardial injury or myocyte cell death
There has been some chest pain evaluation practice in the ED using the graded exercise testing to screen for severe ischaemia
Several studies have suggested the safety of exercise testing in low risk patients presenting to ED with chest painThe use of exercise testing has been found to be a powerful tool for prognostication
Stress nuclear imaging was also performed at the end of 6 hours of observation instead of graded exercise stress testing alone There will be a significant proportion of patients who will not be eligible for standard exercise treadmill stress test due to poor exercise tolerance Even for those who underwent exercise testing studies showed that 242 were inconclusive because of baseline ECG abnormalities left ventricular hypertrophy left bundle-branch block or patient on digoxin Some patients may not be able to achieve the required exercise level
Studies have shown that the mean sensitivity and specificity for graded exercise testing to detect severe coronary artery disease were 68 and 77 respectively The sensitivity of graded exercise test for detecting single vessel disease is lower
Stress nuclear imaging is valuable in establishing the prognosis of patients with a low likelihood of coronary artery disease Stress nuclear scans have additive prognostic value to graded exercise test especially if the latter is abnormal or non-diagnosticFor those who cannot exercise pharmacological stress tetrofosmin with dobutamine or adenosine will be performed instead
The efficacy of acute chest pain evaluation centre has not been compared with a conventional protocol in a prospective randomised clinical trial
Aims
1 To compare the incidence of adverse cardiac events among patients discharged after evaluation through ACTION with those through conventional protocol Adverse cardiac events are defined as any of the following
i Cardiac related death ii Ventricular fibrillation iii Myocardial infarction iv Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance v Acute pulmonary oedema requiring endotracheal intubation
2 To study the sensitivity specificity graded exercises testing stress tetrofosmin scan in predicting adverse cardiac event
5 Treatment Plan
First 6 hours Once informed consent was obtained the patient was then enrolled They were put on continuous ECG monitoring Ten mls of blood were drawn at 036 hours after arrival at the ED for myoglobin CKMB and TnT analysis Blood for LDL HDL were also drawn at 0 hour as well with the cardiac markers The old hospital case record of patient if available were retrieved and previous ECGs were also compared against the new ECG
Patients who develop recurring chest pain consistent with myocardial ischaemia ST segment elevation or depression on continuous 12 lead ECG monitoring indicating myocardial necrosis or have positive CKMB 5 Troponin T 001 were admitted to the Department of Cardiology If the patient was not admitted at the end of 6 hours heshe were reviewed by a ED RegistrarAssociate ConsultantConsultant The senior ED doctor reviewed the patient his her 12 lead ECGs and blood results for serum markers for myocardial necrosis
After first 6 hours - Study Group Intervention Protocol
The patient then underwent a stress tetrofosmin scan within 24 hours of presentation exercise or pharmacological stress for those who cannot exercise Tetrofosmin scans was be done at NHC or the Department of Nuclear Medicine SGH Patients were monitored until the test was completed If the stress tetrofosmin scan turned out to be positive the patient was then admitted to the hospital for further management If the stress tetrofosmin scan was negative the patient was released from ED with instructions for follow-up in the cardiology clinic as an outpatient
Control Group conventional protocol The patient with high or intermediate risk for coronary artery disease CAD as defined by Agency for HealthCare Policy and Research guidelines for Unstable Angina was admitted The indicators for coronary artery disease are definite angina T wave inversion 1 mm in leads with dominant R waves and diabetes If in doubt patients were also admitted Patients who were discharged from the ED will be reviewed by a cardiologist at the NHC cardiac clinic within two weeks
6 Follow Up
Patients were followed up at one month six months and one year for any primary or secondary endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None