Low Risk Acute Coronary Syndrome
Conditions
Keywords
Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing
Brief summary
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.
Interventions
PROCEDUREStress Test
PROCEDURENo Stress Test
Sponsors
VA Office of Research and Development
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. TIMI score \< or = to 2(12) 2. TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels 3. Normal cardiac biomarkers (3 sets over 12-88 hours) 4. No evidence of acute ischemia on electrocardiograms 5. Normal ejection fraction (\>40%) on echocardiography 6. Age 30-75 7. Ability to complete noninvasive stress test 8. Ability to provide informed consent
Exclusion criteria
1. Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis) 2. Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia 3. Evidence of ischemia on electrocardiogram 4. Abnormal cardiac biomarkers 5. History of medical noncompliance or social circumstances preventing compliance 6. Life span estimated at \<1 year 7. Pregnancy 8. Refusal to sign consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization | one year | Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects. | one year | Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects. |
Countries
United States
Outcome results
None listed