Acute Chest Pain Treatment and Evaluation (ACTION) Study
Information source: Singapore General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chest Pain
Intervention: Stress nuclear scan (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Singapore General Hospital Official(s) and/or principal investigator(s): Lim S Han, MBBS, FRCS, Principal Investigator, Affiliation: Department of Emergency Medicine, Singapore General Hospital
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 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cardiac related deathVentricular Fibrillation Myocardial Infarction Cardiogenic shock requiring intra-aortic balloon pump circulatory assistance Acute pulmonary oedema requiring endotracheal intubation
Secondary outcome: Requirement of emergency coronary revascularisation procedures like Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG)
Detailed description:
Identifying the cause of chest pain is a challenge to the Emergency Physician. Coronary
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 (ED)with AMI or unstable angina develop poor outcomes. This is because a large
proportion of AMI present atypically. The initial single 12 lead ECG done at an ED is only
50% sensitive for AMI. Serial ECGs have been shown to improve sensitivity by 25%.Because 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 pain. The 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 24. 2% 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-diagnostic. For 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 0,3,6 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 ECG’s 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 (> 0. 01), were admitted to the Department of
Cardiology. If the patient was not admitted at the end of 6 hours, he/she were reviewed by a
ED Registrar/Associate Consultant/Consultant. 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.
Eligibility
Minimum age: 25 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 25 years and above
- Chest pain suggestive of the angina
- 12 leads ECG non-diagnostic for myocardial ischaemia or AMI
- diabetes mellitus
- family history of young AMI (less than 50 years old) There is no lower limit of age
for those patients in the last two categories
Exclusion Criteria:
- ECG diagnostic of AMI or acute myocardial ischaemia (as defined by the new Q wave ,
ST elevation or depression greater than 1mm or 0. 1 millivolts in two or more
contiguous leads)
- Congestive heart failure or hypotensive patients
- Persistent chest pain consistent with unstable angina
Locations and Contacts
Singapore General Hospital, Singapore, Singapore
Additional Information
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Starting date: August 2000
Last updated: February 12, 2007
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