Randomized Comparison Angioplasty Outcomes at Hospitals With and Without on-Site Cardiac Surgery - Full Text View

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)

MedlinePlus related topics:

Angina Angioplasty Coronary Artery Disease Heart Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized Comparison Angioplasty Outcomes at Hospitals With and Without on-Site Cardiac Surgery

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:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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

Contacts


Contact: Thomas Aversano, MD	410-550-9821	taversan@jhmi.edu

Locations


United States, Alabama
	Crestwood Medical Center	Recruiting
	Huntsville, Alabama, United States, 35801

United States, Georgia
	Archbold Memorial Hospital	Recruiting
	Thomasville, Georgia, United States, 31792
	Contact: Richard Kerensky, MD 229-551-0083
	Fairview Park Hospital	Active, not recruiting
	Dublin, Georgia, United States, 31021
	Spalding Regional Medical Center	Recruiting
	Griffin, Georgia, United States
	Southeast Georgia Health System	Recruiting
	Brunswick, Georgia, United States
	Southern Regional Medical Center	Recruiting
	Riverdale, Georgia, United States
	Hamilton Medical Center	Recruiting
	Dalton, Georgia, United States, 30722
	Tanner Medical Center	Recruiting
	Carrollton, Georgia, United States
	Tift Regional Medical Center	Recruiting
	Tifton, Georgia, United States
	Wellstar Cobb Hospital	Recruiting
	Austell, Georgia, United States

United States, Illinois
	Advocate South Suburban Hospital	Recruiting
	Hazel Crest, Illinois, United States, 60429
	Little Company of Mary Hospital	Recruiting
	Evergreen Park, Illinois, United States

United States, New Jersey
	Bayonne Medical Center	Recruiting
	Bayonne, New Jersey, United States, 07002
	Holy Name Hospital	Recruiting
	Teaneck, New Jersey, United States
	Monmouth Medical Center	Recruiting
	Long Branch, New Jersey, United States
	Muhlenberg Regional Medical Center	Recruiting
	South Plainfield, New Jersey, United States
	Raritan Bay Medical Center	Recruiting
	Perth Amboy, New Jersey, United States
	Robert Wood Johnson Medical Center	Recruiting
	Hamilton, New Jersey, United States
	Somerset Medical Center	Recruiting
	Somerville, New Jersey, United States
	Trinitas Hospital	Recruiting
	Elizabeth, New Jersey, United States
	Virtua-West Jersey Hospital Marlton	Recruiting
	Evesham, New Jersey, United States

United States, North Carolina
	Duke Health Raleigh Hospital	Recruiting
	Raleigh, North Carolina, United States, 27609
	Rowan Regional Medical Center	Recruiting
	Salisbury, North Carolina, United States

United States, Ohio
	Community Health and Wellness Center	Recruiting
	Bryan, Ohio, United States, 43506
	Fort Hamilton Hospital	Recruiting
	Fort Hamilton, Ohio, United States
	Knox Community Hospital	Recruiting
	Mount Vernon, Ohio, United States
	Southern Ohio Medical Center	Recruiting
	Portsmouth, Ohio, United States

United States, Oregon
	Legacy Meridian Park Hospital	Recruiting
	Portland, Oregon, United States

United States, Texas
	Kingwood Medical Center	Recruiting
	Kingwood, Texas, United States

Sponsors and Collaborators

Johns Hopkins University

Investigators


Study Director:	Thomas Aversano, MD	Johns Hopkins Medical Institutions

More Information

Responsible Party:	Johns Hopkins University ( Thomas Aversano )
Study ID Numbers:	NA_000230, C-PORT E Trial
First Received:	October 24, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00549796
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

Study placed in the following topic categories:

Coronary Disease

Arterial Occlusive Diseases

Signs and Symptoms

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Angina Pectoris

Pain

Ischemia

Arteriosclerosis

Coronary Artery Disease

Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00549796