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

September 10, 2014 updated by: Thomas Aversano, Johns Hopkins University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18876

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Crestwood Medical Center
    • Georgia
      • Austell, Georgia, United States
        • WellStar Cobb Hospital
      • Brunswick, Georgia, United States
        • Southeast Georgia Health system
      • Carrollton, Georgia, United States
        • Tanner Medical Center
      • Dalton, Georgia, United States, 30722
        • Hamilton Medical Center
      • Dublin, Georgia, United States, 31021
        • Fairview Park Hospital
      • Griffin, Georgia, United States
        • Spalding Regional Medical Center
      • LaGrange, Georgia, United States
        • West Georgia Health
      • Riverdale, Georgia, United States
        • Southern Regional Medical Center
      • Thomasville, Georgia, United States, 31792
        • Archbold Memorial Hospital
      • Tifton, Georgia, United States
        • Tift Regional Medical Center
    • Illinois
      • Evergreen Park, Illinois, United States
        • Little Company of Mary Hospital
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
    • Maryland
      • Annapolis, Maryland, United States
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, United States
        • St. Agnes Hospital
      • Clinton, Maryland, United States
        • Southern Maryland Hospital Center
      • Frederick, Maryland, United States
        • Frederick Memorial Hospital
      • Glen Burnie, Maryland, United States
        • Baltimore Washington Medical Center
      • Hagerstown, Maryland, United States
        • Meritus Medical Center
      • Rockville, Maryland, United States
        • Shady Grove Adventist Hospital
      • Silver Spring, Maryland, United States
        • Holy Cross Hospital
    • New Jersey
      • Bayonne, New Jersey, United States, 07002
        • Bayonne Medical Center
      • Belleville, New Jersey, United States
        • Clara Maas Medical Center
      • Edison, New Jersey, United States
        • JFK Medical Center
      • Elizabeth, New Jersey, United States
        • Trinitas Hospital
      • Evesham, New Jersey, United States
        • Virtua-West Jersey Hospital Marlton
      • Hamilton, New Jersey, United States
        • Robert Wood Johnson Medical Center
      • Long Branch, New Jersey, United States
        • Monmouth Medical Center
      • Perth Amboy, New Jersey, United States
        • Raritan Bay Medical Center
      • Red Bank, New Jersey, United States
        • Riverview Medical Center
      • Somerville, New Jersey, United States
        • Somerset Medical Center
      • South Plainfield, New Jersey, United States
        • Muhlenberg Regional Medical Center
      • Summit, New Jersey, United States
        • Overlook Medical Center
      • Teaneck, New Jersey, United States
        • Holy Name Hospital
      • Toms River, New Jersey, United States
        • Community Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Duke Health Raleigh Hospital
      • Salisbury, North Carolina, United States
        • Rowan Regional Medical Center
    • Ohio
      • Bryan, Ohio, United States, 43506
        • Community Health and Wellness Center
      • Chardon, Ohio, United States
        • University Hospitals Case Medical Center / Geauga Medical Center
      • Columbus, Ohio, United States
        • University Hospital East Ohio State University Medical Center
      • Dayton, Ohio, United States
        • Southview Medical Center
      • Fort Hamilton, Ohio, United States
        • Fort Hamilton Hospital
      • Marietta, Ohio, United States
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, United States
        • Knox Community Hospital
      • Newark, Ohio, United States
        • Licking Memorial Hospital
      • Portsmouth, Ohio, United States
        • Southern Ohio Medical Center
      • Westerville, Ohio, United States
        • Mt. Carmel St. Ann's Hospital
    • Oregon
      • Portland, Oregon, United States
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Sacred Heart Hospital
      • Chambersburg, Pennsylvania, United States
        • Chambersburg Hospital
      • Kittanning, Pennsylvania, United States
        • Armstrong County Memorial Hospital
      • Lewisburg, Pennsylvania, United States
        • Evangelical Community Hospital
      • McKeesport, Pennsylvania, United States
        • UPMC McKeesport
      • Meadville, Pennsylvania, United States
        • Meadville Medical Center
      • Monongahela, Pennsylvania, United States
        • Monongahela Valley Hospital
      • West Chester, Pennsylvania, United States
        • West Chester Hospital
      • York, Pennsylvania, United States
        • Memorial Hospital
    • Texas
      • Kingwood, Texas, United States
        • Kingwood Medical Center
      • Texas City, Texas, United States
        • Mainland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: 2
PCI performed at a hospitals without co-located (on-site) cardiac surgery
Other: Percutaneous coronary intervention (PCI)
Patients undergo routine, clinically indicated PCI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mortality
Time Frame: 6 weeks
6 weeks
MACE = death + MI + TVR
Time Frame: 9 Months
9 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
emergency CABG
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
myocardial infarction
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
target vessel revascularization (TVR)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
any subsequent revascularization (ASR)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
heart failure and class
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
angina and class
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
stroke
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
composite adverse endpoint (MACE)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
MACE = death + MI + TVR
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
MACE = death + MI + ASR
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
completeness of revascularization
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
percent of patients with complete or partial revascularization
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
bleeding (non-CABG transfusion, vascular repair)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
length of stay
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
total direct medical cost
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months
major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)
Time Frame: hosp DC, 6 wks, 3, 6 and 9 months
hosp DC, 6 wks, 3, 6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Maryland Medical Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Aversano, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA_000230
  • C-PORT E Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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