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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT00549796

Public ClinicalTrials.gov record NCT00549796. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 10:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00549796
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Johns Hopkins University
Other
Enrollment
18,876 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2006
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012
Last update posted
Sep 10, 2014

2006 – 2012

United States locations

U.S. sites
60
U.S. states
10
U.S. cities
59
Facility City State ZIP Site status
Crestwood Medical Center Huntsville Alabama 35801
Wellstar Cobb Hospital Austell Georgia
Southeast Georgia Health System Brunswick Georgia
Tanner Medical Center Carrollton Georgia
Hamilton Medical Center Dalton Georgia 30722
Fairview Park Hospital Dublin Georgia 31021
Spalding Regional Medical Center Griffin Georgia
West Georgia Health La Grange Georgia
Southern Regional Medical Center Riverdale Georgia
Archbold Memorial Hospital Thomasville Georgia 31792
Tift Regional Medical Center Tifton Georgia
Little Company of Mary Hospital Evergreen Park Illinois
Advocate South Suburban Hospital Hazel Crest Illinois 60429
Anne Arundel Medical Center Annapolis Maryland
Johns Hopkins Bayview Medical Center Baltimore Maryland
St. Agnes Hospital Baltimore Maryland
Southern Maryland Hospital Center Clinton Maryland
Frederick Memorial Hospital Frederick Maryland
Baltimore Washington Medical Center Glen Burnie Maryland
Meritus Medical Center Hagerstown Maryland
Shady Grove Adventist Hospital Rockville Maryland
Holy Cross Hospital Silver Spring Maryland
Bayonne Medical Center Bayonne New Jersey 07002
Clara Maas Medical Center Belleville New Jersey
JFK Medical Center Edison New Jersey
Trinitas Hospital Elizabeth New Jersey
Robert Wood Johnson Medical Center Hamilton New Jersey
Monmouth Medical Center Long Branch New Jersey
Virtua-West Jersey Hospital Marlton Marlton New Jersey
Raritan Bay Medical Center Perth Amboy New Jersey
Riverview Medical Center Red Bank New Jersey
Somerset Medical Center Somerville New Jersey
Muhlenberg Regional Medical Center South Plainfield New Jersey
Overlook Medical Center Summit New Jersey
Holy Name Hospital Teaneck New Jersey
Community Medical Center Toms River New Jersey
Duke Health Raleigh Hospital Raleigh North Carolina 27609
Rowan Regional Medical Center Salisbury North Carolina
Community Health and Wellness Center Bryan Ohio 43506
University Hospitals Case Medical Center / Geauga Medical Center Chardon Ohio
University Hospital East Ohio State University Medical Center Columbus Ohio
Southview Medical Center Dayton Ohio
Fort Hamilton Hospital Hamilton Ohio
Marietta Memorial Hospital Marietta Ohio
Knox Community Hospital Mount Vernon Ohio
Licking Memorial Hospital Newark Ohio
Southern Ohio Medical Center Portsmouth Ohio
Mt. Carmel St. Ann's Hospital Westerville Ohio
Legacy Meridian Park Hospital Portland Oregon
Sacred Heart Hospital Allentown Pennsylvania
Chambersburg Hospital Chambersburg Pennsylvania
Armstrong County Memorial Hospital Kittanning Pennsylvania
Evangelical Community Hospital Lewisburg Pennsylvania
UPMC McKeesport McKeesport Pennsylvania
Meadville Medical Center Meadville Pennsylvania
Monongahela Valley Hospital Monongahela Pennsylvania
West Chester Hospital West Chester Pennsylvania
Memorial Hospital York Pennsylvania
Kingwood Medical Center Kingwood Texas
Mainland Medical Center Texas City Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00549796, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2014 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00549796 live on ClinicalTrials.gov.

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