Low Risk Acute Coronary Syndrome (LOW ACT)

University of Oklahoma (OU)

Status: Completed

Conditions: Low Risk Acute Coronary Syndrome

Treatments: Procedure: Stress Test; Procedure: No Stress Test

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01703156

Low Risk ACS

IRB#14542 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Non-Stress Group

Experimental group

Description:

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.

Treatment:

Procedure: No Stress Test

Stress Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Stress Test