NCT00549796

Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18,876 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Arteriosclerosis
• Angina Pectoris

Interventions

Type	Name	Description
OTHER	Percutaneous coronary intervention (PCI)	Patients undergo routine, clinically indicated PCI

Timeline

• Start date: 2006-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2007-10-26
• Last updated: 2014-09-11

Locations

60 sites across 1 country: United States