Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
NCT ID: NCT00549796
Last Updated: 2014-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18876 participants
INTERVENTIONAL
2006-04-30
2012-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1
PCI performed at a hospital with co-located (on-site) cardiac surgery
Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
2
PCI performed at a hospitals without co-located (on-site) cardiac surgery
Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
Interventions
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Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Maryland Medical Research Institute
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Thomas Aversano
Associate Professor of Medicine
Principal Investigators
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Thomas Aversano, MD
Role: STUDY_DIRECTOR
Johns Hopkins University
Locations
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Crestwood Medical Center
Huntsville, Alabama, 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, 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
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, United States
Rowan Regional Medical Center
Salisbury, North Carolina, United States
Community Health and Wellness Center
Bryan, Ohio, 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
Countries
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References
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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.
Aversano 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.
Other Identifiers
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C-PORT E Trial
Identifier Type: -
Identifier Source: secondary_id
NA_000230
Identifier Type: -
Identifier Source: org_study_id
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