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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Duke University
Maryland Medical Research Institute
Information provided by (Responsible Party):
Thomas Aversano, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00549796
First received: October 24, 2007
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Coronary Arteriosclerosis
Angina Pectoris
Other: Percutaneous coronary intervention (PCI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mortality [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • MACE = death + MI + TVR [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • emergency CABG [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • target vessel revascularization (TVR) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • any subsequent revascularization (ASR) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • heart failure and class [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • angina and class [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • stroke [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • composite adverse endpoint (MACE) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • MACE = death + MI + TVR [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • MACE = death + MI + ASR [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • angiographic (end-procedure) complications (embolization, dissection, no reflow, etc) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • completeness of revascularization [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • percent of patients with complete or partial revascularization [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • bleeding (non-CABG transfusion, vascular repair) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: Yes ]
  • length of stay [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • total direct medical cost [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations) [ Time Frame: hosp DC, 6 wks, 3, 6 and 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18000
Study Start Date: April 2006
Estimated Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PCI performed at a hospital with co-located (on-site) cardiac surgery
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI
2
PCI performed at a hospitals without co-located (on-site) cardiac surgery
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549796

Locations
United States, Alabama
Crestwood Medical Center
Huntsville, Alabama, United States, 35801
United States, Georgia
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, 30722
Fairview Park Hospital
Dublin, Georgia, United States, 31021
Spalding Regional Medical Center
Griffin, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Archbold Memorial Hospital
Thomasville, Georgia, United States, 31792
Tift Regional Medical Center
Tifton, Georgia, United States
United States, Illinois
Little Company of Mary Hospital
Evergreen Park, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States, 60429
United States, New Jersey
Bayonne Medical Center
Bayonne, New Jersey, United States, 07002
Trinitas Hospital
Elizabeth, New Jersey, United States
Virtua-West Jersey Hospital Marlton
Evesham, New Jersey, United States
Robert Wood Johnson Medical Center
Hamilton, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Raritan Bay Medical Center
Perth Amboy, 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
United States, North Carolina
Duke Health Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Rowan Regional Medical Center
Salisbury, North Carolina, United States
United States, Ohio
Community Health and Wellness Center
Bryan, Ohio, United States, 43506
Fort Hamilton Hospital
Fort Hamilton, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
United States, Oregon
Legacy Meridian Park Hospital
Portland, Oregon, United States
United States, Texas
Kingwood Medical Center
Kingwood, Texas, United States
Sponsors and Collaborators
Johns Hopkins University
Duke University
Maryland Medical Research Institute
Investigators
Study Director: Thomas Aversano, MD Johns Hopkins Medical Institutions
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Aversano, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00549796     History of Changes
Other Study ID Numbers: NA_000230, C-PORT E Trial
Study First Received: October 24, 2007
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
coronary artery disease
angioplasty
stent
percutaneous coronary intervention
on-site cardiac surgery
randomized trial

Additional relevant MeSH terms:
Angina Pectoris
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arterial Occlusive Diseases
Coronary Disease

ClinicalTrials.gov processed this record on April 17, 2014