Angina Pectoris Clinical Trial
Official title:
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents.
Most U.S. states and all national heart organizations require that angioplasty be done only
at hospitals that can also perform open heart surgery. The reason for this is that there is
a risk that angioplasty can cause injury to the heart artery that might require open heart
surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open
heart surgery will be needed is very small. Nevertheless, without more research, many state
Departments of Health and all national heart organizations do not want to change the
requirement for having on-site open heart surgery wherever angioplasty is performed. Some
States already allow this; and European heart organizations already allow it, as well.
This study is designed to determine whether the safety and benefits of angioplasty are the
same at hospitals that perform angioplasty either with or without open heart surgery backup.
Patient who enter the study have a heart catheterization at a hospital without a heart
surgery program. If they need angioplasty, then they are randomized to either stay at the
hospital without heart surgery for their angioplasty or to be transferred for the procedure
to a hospital with heart surgery. For every four patients, three stay at the hospital
without heart surgery and one is transferred.
The study is designed to show that there is no detectable difference between the safety and
benefits of the procedure at the two types of hospital (with and without heart surgery). The
cost of the procedure at the two hospital types is also compared.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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