Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
- Conditions
- Coronary ArteriosclerosisAngina Pectoris
- Interventions
- Other: Percutaneous coronary intervention (PCI)
- Registration Number
- NCT00549796
- Lead Sponsor
- Johns Hopkins University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18876
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Percutaneous coronary intervention (PCI) PCI performed at a hospitals without co-located (on-site) cardiac surgery 1 Percutaneous coronary intervention (PCI) PCI performed at a hospital with co-located (on-site) cardiac surgery
- Primary Outcome Measures
Name Time Method Mortality 6 weeks MACE = death + MI + TVR 9 Months
- Secondary Outcome Measures
Name Time Method emergency CABG hosp DC, 6 wks, 3, 6 and 9 months target vessel revascularization (TVR) hosp DC, 6 wks, 3, 6 and 9 months any subsequent revascularization (ASR) hosp DC, 6 wks, 3, 6 and 9 months heart failure and class hosp DC, 6 wks, 3, 6 and 9 months composite adverse endpoint (MACE) hosp DC, 6 wks, 3, 6 and 9 months myocardial infarction hosp DC, 6 wks, 3, 6 and 9 months stroke hosp DC, 6 wks, 3, 6 and 9 months total direct medical cost hosp DC, 6 wks, 3, 6 and 9 months angina and class hosp DC, 6 wks, 3, 6 and 9 months angiographic (end-procedure) complications (embolization, dissection, no reflow, etc) hosp DC, 6 wks, 3, 6 and 9 months angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow) hosp DC, 6 wks, 3, 6 and 9 months MACE = death + MI + TVR hosp DC, 6 wks, 3, 6 and 9 months major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations) hosp DC, 6 wks, 3, 6 and 9 months MACE = death + MI + ASR hosp DC, 6 wks, 3, 6 and 9 months completeness of revascularization hosp DC, 6 wks, 3, 6 and 9 months percent of patients with complete or partial revascularization hosp DC, 6 wks, 3, 6 and 9 months bleeding (non-CABG transfusion, vascular repair) hosp DC, 6 wks, 3, 6 and 9 months length of stay hosp DC, 6 wks, 3, 6 and 9 months
Trial Locations
- Locations (60)
Robert Wood Johnson Medical Center
🇺🇸Hamilton, New Jersey, United States
Raritan Bay Medical Center
🇺🇸Perth Amboy, New Jersey, United States
Clara Maas Medical Center
🇺🇸Belleville, New Jersey, United States
Virtua-West Jersey Hospital Marlton
🇺🇸Evesham, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
Crestwood Medical Center
🇺🇸Huntsville, Alabama, United States
Wellstar Cobb Hospital
🇺🇸Austell, Georgia, United States
Southeast Georgia Health System
🇺🇸Brunswick, Georgia, United States
Duke Health Raleigh Hospital
🇺🇸Raleigh, North Carolina, 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
Rowan Regional Medical Center
🇺🇸Salisbury, North Carolina, United States
West Georgia Health
🇺🇸LaGrange, Georgia, United States
University Hospitals Case Medical Center / Geauga Medical Center
🇺🇸Chardon, Ohio, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Tift Regional Medical Center
🇺🇸Tifton, Georgia, United States
Little Company of Mary Hospital
🇺🇸Evergreen Park, Illinois, United States
University Hospital East Ohio State University Medical Center
🇺🇸Columbus, Ohio, 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
Southern Maryland Hospital Center
🇺🇸Clinton, Maryland, United States
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Marietta Memorial Hospital
🇺🇸Marietta, Ohio, 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
JFK Medical Center
🇺🇸Edison, New Jersey, United States
Trinitas Hospital
🇺🇸Elizabeth, New Jersey, United States
Somerset Medical Center
🇺🇸Somerville, New Jersey, United States
Muhlenberg Regional Medical Center
🇺🇸South Plainfield, New Jersey, United States
Holy Name Hospital
🇺🇸Teaneck, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Community Health and Wellness Center
🇺🇸Bryan, Ohio, United States
Southview Medical Center
🇺🇸Dayton, Ohio, United States
Fort Hamilton Hospital
🇺🇸Fort Hamilton, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
Mt. Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
Legacy Meridian Park Hospital
🇺🇸Portland, Oregon, United States
Sacred Heart Hospital
🇺🇸Allentown, Pennsylvania, United States
Chambersburg Hospital
🇺🇸Chambersburg, Pennsylvania, United States
Armstrong County Memorial Hospital
🇺🇸Kittanning, Pennsylvania, United States
Evangelical Community Hospital
🇺🇸Lewisburg, Pennsylvania, United States
Meadville Medical Center
🇺🇸Meadville, Pennsylvania, United States
UPMC McKeesport
🇺🇸McKeesport, Pennsylvania, United States
Monongahela Valley Hospital
🇺🇸Monongahela, Pennsylvania, United States
Memorial Hospital
🇺🇸York, Pennsylvania, United States
Kingwood Medical Center
🇺🇸Kingwood, Texas, United States
West Chester Hospital
🇺🇸West Chester, Pennsylvania, United States
Mainland Medical Center
🇺🇸Texas City, Texas, United States
Archbold Memorial Hospital
🇺🇸Thomasville, Georgia, United States