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

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549796
• Other study ID #: NA_000230
• Secondary ID: C-PORT E Trial
• Status: Completed
• Phase: N/A
• First received: October 24, 2007
• Last updated: September 10, 2014
• Start date: April 2006
• Est. completion date: February 2012

Study information

• Verified date: September 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18876
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Angina Pectoris
• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Other:
• Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Duke University, Maryland Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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