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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#14542 | Other Identifier | University of Oklahoma Health Sciences Center Institutional Review Board |
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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Stress Group | Experimental | Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group. |
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| Stress Group | Active Comparator | Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Test | Procedure |
| ||
| No Stress Test |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization | 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). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects. | Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazen S Abu-Fadel, MD, FACC, FSCAI | OUHSC and VAMC OKC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veteran's Affairs Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| one year |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |