Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
2 other identifiers
interventional
18,876
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedSeptember 11, 2014
September 1, 2014
5.8 years
October 24, 2007
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality
6 weeks
MACE = death + MI + TVR
9 Months
Secondary Outcomes (18)
emergency CABG
hosp DC, 6 wks, 3, 6 and 9 months
myocardial infarction
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
- +13 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORPCI performed at a hospital with co-located (on-site) cardiac surgery
2
OTHERPCI performed at a hospitals without co-located (on-site) cardiac surgery
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Duke Universitycollaborator
- Maryland Medical Research Institutecollaborator
Study Sites (60)
Crestwood Medical Center
Huntsville, Alabama, 35801, United States
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, 30722, United States
Fairview Park Hospital
Dublin, Georgia, 31021, 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, 31792, 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, 60429, 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, 07002, United States
Clara Maas Medical Center
Belleville, New Jersey, United States
JFK Medical Center
Edison, New Jersey, United States
Trinitas Hospital
Elizabeth, New Jersey, United States
Robert Wood Johnson Medical Center
Hamilton, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Virtua-West Jersey Hospital Marlton
Marlton, New Jersey, United States
Raritan Bay Medical Center
Perth Amboy, New Jersey, United States
Riverview Medical Center
Red Bank, New Jersey, United States
Somerset Medical Center
Somerville, New Jersey, United States
Muhlenberg Regional Medical Center
South Plainfield, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Duke Health Raleigh Hospital
Raleigh, North Carolina, 27609, United States
Rowan Regional Medical Center
Salisbury, North Carolina, United States
Community Health and Wellness Center
Bryan, Ohio, 43506, United States
University Hospitals Case Medical Center / Geauga Medical Center
Chardon, Ohio, United States
University Hospital East Ohio State University Medical Center
Columbus, Ohio, United States
Southview Medical Center
Dayton, Ohio, United States
Fort Hamilton Hospital
Hamilton, Ohio, United States
Marietta Memorial Hospital
Marietta, 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
UPMC McKeesport
McKeesport, Pennsylvania, United States
Meadville Medical Center
Meadville, Pennsylvania, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States
West Chester Hospital
West Chester, Pennsylvania, United States
Memorial Hospital
York, Pennsylvania, United States
Kingwood Medical Center
Kingwood, Texas, United States
Mainland Medical Center
Texas City, Texas, United States
Related Publications (2)
Hiremath PG, Aversano T, Spertus JA, Lemmon CC, Naiman DQ, Czarny MJ. Sex Differences in Health Status and Clinical Outcomes After Nonprimary Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Feb;15(2):e011308. doi: 10.1161/CIRCINTERVENTIONS.121.011308. Epub 2022 Jan 23.
PMID: 35067071DERIVEDAversano T, Lemmon CC, Liu L; Atlantic CPORT Investigators. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2012 May 10;366(19):1792-802. doi: 10.1056/NEJMoa1114540. Epub 2012 Mar 25.
PMID: 22443460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Aversano, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
April 1, 2006
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
September 11, 2014
Record last verified: 2014-09