Clinical Trial: Low Risk Acute Coronary Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study

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.

Detailed Summary:
Sponsor: University of Oklahoma

Current Primary Outcome: Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects. [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Oklahoma

Dates:
Date Received: October 3, 2012
Date Started: May 2009
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017