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

Primary Purpose

Coronary Arteriosclerosis, Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous coronary intervention (PCI)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Arteriosclerosis focused on measuring coronary artery disease, angioplasty, stent, percutaneous coronary intervention, on-site cardiac surgery, randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

  • Crestwood Medical Center
  • Wellstar Cobb Hospital
  • Southeast Georgia Health System
  • Tanner Medical Center
  • Hamilton Medical Center
  • Fairview Park Hospital
  • Spalding Regional Medical Center
  • West Georgia Health
  • Southern Regional Medical Center
  • Archbold Memorial Hospital
  • Tift Regional Medical Center
  • Little Company of Mary Hospital
  • Advocate South Suburban Hospital
  • Anne Arundel Medical Center
  • Johns Hopkins Bayview Medical Center
  • St. Agnes Hospital
  • Southern Maryland Hospital Center
  • Frederick Memorial Hospital
  • Baltimore Washington Medical Center
  • Meritus Medical Center
  • Shady Grove Adventist Hospital
  • Holy Cross Hospital
  • Bayonne Medical Center
  • Clara Maas Medical Center
  • JFK Medical Center
  • Trinitas Hospital
  • Virtua-West Jersey Hospital Marlton
  • Robert Wood Johnson Medical Center
  • Monmouth Medical Center
  • Raritan Bay Medical Center
  • Riverview Medical Center
  • Somerset Medical Center
  • Muhlenberg Regional Medical Center
  • Overlook Medical Center
  • Holy Name Hospital
  • Community Medical Center
  • Duke Health Raleigh Hospital
  • Rowan Regional Medical Center
  • Community Health and Wellness Center
  • University Hospitals Case Medical Center / Geauga Medical Center
  • University Hospital East Ohio State University Medical Center
  • Southview Medical Center
  • Fort Hamilton Hospital
  • Marietta Memorial Hospital
  • Knox Community Hospital
  • Licking Memorial Hospital
  • Southern Ohio Medical Center
  • Mt. Carmel St. Ann's Hospital
  • Legacy Meridian Park Hospital
  • Sacred Heart Hospital
  • Chambersburg Hospital
  • Armstrong County Memorial Hospital
  • Evangelical Community Hospital
  • UPMC McKeesport
  • Meadville Medical Center
  • Monongahela Valley Hospital
  • West Chester Hospital
  • Memorial Hospital
  • Kingwood Medical Center
  • Mainland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

PCI performed at a hospital with co-located (on-site) cardiac surgery

PCI performed at a hospitals without co-located (on-site) cardiac surgery

Outcomes

Primary Outcome Measures

Mortality
MACE = death + MI + TVR

Secondary Outcome Measures

emergency CABG
myocardial infarction
target vessel revascularization (TVR)
any subsequent revascularization (ASR)
heart failure and class
angina and class
stroke
composite adverse endpoint (MACE)
MACE = death + MI + TVR
MACE = death + MI + ASR
angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)
angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)
completeness of revascularization
percent of patients with complete or partial revascularization
bleeding (non-CABG transfusion, vascular repair)
length of stay
total direct medical cost
major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)

Full Information

First Posted
October 24, 2007
Last Updated
September 10, 2014
Sponsor
Johns Hopkins University
Collaborators
Duke University, Maryland Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00549796
Brief Title
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Official Title
Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Duke University, Maryland Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Angina Pectoris
Keywords
coronary artery disease, angioplasty, stent, percutaneous coronary intervention, on-site cardiac surgery, randomized trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18876 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
PCI performed at a hospital with co-located (on-site) cardiac surgery
Arm Title
2
Arm Type
Other
Arm Description
PCI performed at a hospitals without co-located (on-site) cardiac surgery
Intervention Type
Other
Intervention Name(s)
Percutaneous coronary intervention (PCI)
Intervention Description
Patients undergo routine, clinically indicated PCI
Primary Outcome Measure Information:
Title
Mortality
Time Frame
6 weeks
Title
MACE = death + MI + TVR
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
emergency CABG
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
myocardial infarction
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
target vessel revascularization (TVR)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
any subsequent revascularization (ASR)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
heart failure and class
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
angina and class
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
stroke
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
composite adverse endpoint (MACE)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
MACE = death + MI + TVR
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
MACE = death + MI + ASR
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
completeness of revascularization
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
percent of patients with complete or partial revascularization
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
bleeding (non-CABG transfusion, vascular repair)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
length of stay
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
total direct medical cost
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months
Title
major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)
Time Frame
hosp DC, 6 wks, 3, 6 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Aversano, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
Facility Information:
Facility Name
Crestwood Medical Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Wellstar Cobb Hospital
City
Austell
State/Province
Georgia
Country
United States
Facility Name
Southeast Georgia Health System
City
Brunswick
State/Province
Georgia
Country
United States
Facility Name
Tanner Medical Center
City
Carrollton
State/Province
Georgia
Country
United States
Facility Name
Hamilton Medical Center
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30722
Country
United States
Facility Name
Fairview Park Hospital
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Spalding Regional Medical Center
City
Griffin
State/Province
Georgia
Country
United States
Facility Name
West Georgia Health
City
LaGrange
State/Province
Georgia
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
Country
United States
Facility Name
Archbold Memorial Hospital
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Tift Regional Medical Center
City
Tifton
State/Province
Georgia
Country
United States
Facility Name
Little Company of Mary Hospital
City
Evergreen Park
State/Province
Illinois
Country
United States
Facility Name
Advocate South Suburban Hospital
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Southern Maryland Hospital Center
City
Clinton
State/Province
Maryland
Country
United States
Facility Name
Frederick Memorial Hospital
City
Frederick
State/Province
Maryland
Country
United States
Facility Name
Baltimore Washington Medical Center
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Meritus Medical Center
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Shady Grove Adventist Hospital
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
Country
United States
Facility Name
Bayonne Medical Center
City
Bayonne
State/Province
New Jersey
ZIP/Postal Code
07002
Country
United States
Facility Name
Clara Maas Medical Center
City
Belleville
State/Province
New Jersey
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Trinitas Hospital
City
Elizabeth
State/Province
New Jersey
Country
United States
Facility Name
Virtua-West Jersey Hospital Marlton
City
Evesham
State/Province
New Jersey
Country
United States
Facility Name
Robert Wood Johnson Medical Center
City
Hamilton
State/Province
New Jersey
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
Country
United States
Facility Name
Raritan Bay Medical Center
City
Perth Amboy
State/Province
New Jersey
Country
United States
Facility Name
Riverview Medical Center
City
Red Bank
State/Province
New Jersey
Country
United States
Facility Name
Somerset Medical Center
City
Somerville
State/Province
New Jersey
Country
United States
Facility Name
Muhlenberg Regional Medical Center
City
South Plainfield
State/Province
New Jersey
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
Holy Name Hospital
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
Duke Health Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Rowan Regional Medical Center
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Community Health and Wellness Center
City
Bryan
State/Province
Ohio
ZIP/Postal Code
43506
Country
United States
Facility Name
University Hospitals Case Medical Center / Geauga Medical Center
City
Chardon
State/Province
Ohio
Country
United States
Facility Name
University Hospital East Ohio State University Medical Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Southview Medical Center
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Fort Hamilton Hospital
City
Fort Hamilton
State/Province
Ohio
Country
United States
Facility Name
Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
Country
United States
Facility Name
Mt. Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
Country
United States
Facility Name
Legacy Meridian Park Hospital
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Sacred Heart Hospital
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Chambersburg Hospital
City
Chambersburg
State/Province
Pennsylvania
Country
United States
Facility Name
Armstrong County Memorial Hospital
City
Kittanning
State/Province
Pennsylvania
Country
United States
Facility Name
Evangelical Community Hospital
City
Lewisburg
State/Province
Pennsylvania
Country
United States
Facility Name
UPMC McKeesport
City
McKeesport
State/Province
Pennsylvania
Country
United States
Facility Name
Meadville Medical Center
City
Meadville
State/Province
Pennsylvania
Country
United States
Facility Name
Monongahela Valley Hospital
City
Monongahela
State/Province
Pennsylvania
Country
United States
Facility Name
West Chester Hospital
City
West Chester
State/Province
Pennsylvania
Country
United States
Facility Name
Memorial Hospital
City
York
State/Province
Pennsylvania
Country
United States
Facility Name
Kingwood Medical Center
City
Kingwood
State/Province
Texas
Country
United States
Facility Name
Mainland Medical Center
City
Texas City
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35067071
Citation
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.
Results Reference
derived
PubMed Identifier
22443460
Citation
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. Erratum In: N Engl J Med. 2012 Apr 26;366(17):1650.
Results Reference
derived

Learn more about this trial

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

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