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

Completed · Not applicable

Conditions studied: Coronary Arteriosclerosis, Angina Pectoris

In brief

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.

Key facts

Study ID

NCT00549796

Run by

Johns Hopkins University

People needed

18876

Starts

2006-04-01

Expected to finish

2012-02-01

Last updated by the study team

2014-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-catheterization:
• Must be undergoing diagnostic cardiac catheterization for suspected CAD
• Be at least 18 years of age
• Must not be pregnant (negative pregnancy test) or must not be of childbearing potential must be able to give informed consent.
• Post-catheterization:
• Coronary artery disease judged to be clinically and angiographically significant
• Ability to perform PCI with equipment available at the local site
• Procedure risk judged to be not high (see below)

You may not qualify if…

• Pre-catheterization:
• Inability to give informed consent
• ST-segment elevation myocardial infarction
• Pregnancy
• Post-catheterization:
• High likelihood of requiring a device not available at the hospitals without SOS
• No need for PCI
• Need for coronary artery bypass surgery
• High procedural risk (see below)
• High procedural risk criteria are:
• PCI of unprotected left main coronary artery
• PCI of left circulation lesion in the presence of critical (>70%) unprotected left main coronary artery lesion
• Poor left ventricular function (EF< 20%) and need to perform PCI in a vessel supplying significant myocardium

Where it is running

• Wellstar Cobb Hospital — Austell, Georgia, United States
• Southeast Georgia Health System — Brunswick, Georgia, United States
• Tanner Medical Center — Carrollton, Georgia, United States
• Hamilton Medical Center — Dalton, Georgia, United States
• Fairview Park Hospital — Dublin, Georgia, United States
• Spalding Regional Medical Center — Griffin, Georgia, United States
• West Georgia Health — La Grange, Georgia, United States
• Southern Regional Medical Center — Riverdale, Georgia, United States
• Archbold Memorial Hospital — Thomasville, Georgia, United States
• Tift Regional Medical Center — Tifton, Georgia, United States
• Little Company of Mary Hospital — Evergreen Park, Illinois, United States
• Advocate South Suburban Hospital — Hazel Crest, Illinois, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• Southern Maryland Hospital Center — Clinton, Maryland, United States
• Frederick Memorial Hospital — Frederick, Maryland, United States
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States
• Meritus Medical Center — Hagerstown, Maryland, United States
• Shady Grove Adventist Hospital — Rockville, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Bayonne Medical Center — Bayonne, New Jersey, United States
• Clara Maas Medical Center — Belleville, New Jersey, United States
• JFK Medical Center — Edison, New Jersey, United States
• Crestwood Medical Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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