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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


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
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