Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site (CPORT)

April 10, 2018 updated by: Johns Hopkins University
This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who were participants in the CPORT-E project. The aim of the registry is simple data collection and reporting to respective State Departments of Health. The registry population consists of patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without SOS and who require PCI.

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.

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.
Observational

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.
31390

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
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21044
        • Hopkins Bayview Medical Center
      • Catonsville, Maryland, United States, 21229
        • St. Agnes Hospital
      • Clinton, Maryland, United States, 20735
        • Southern Maryland Hospital Center
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
      • Glen Burnie, Maryland, United States, 21061
        • Baltimore Washington Medical Center
      • Hagerstown, Maryland, United States, 21742
        • Meritus Medical Center
      • Rockville, Maryland, United States, 20850
        • Shady Grove Adventist Hospital
    • New Jersey
      • Bayonne, New Jersey, United States, 07002
        • Bayonne Medical Center
      • Belleville, New Jersey, United States, 07109
        • Clara Maas Medical Center
      • Edison, New Jersey, United States, 08818
        • JFK Medical Center
      • Elizabeth, New Jersey, United States, 07207
        • Trinitas Hospital
      • Marlton, New Jersey, United States, 08053
        • Virtua West Jersey Hospital
      • Perth Amboy, New Jersey, United States, 08861
        • Raritan Bay Medical Center
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center
      • Somerville, New Jersey, United States, 08876
        • Somerset Medical Center
      • Summit, New Jersey, United States, 07901
        • Overlook Hospital
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • Ohio
      • Bryan, Ohio, United States, 43506
        • Community Health and Wellness Center
      • Chardon, Ohio, United States, 44024
        • University Hospital Geauga Medical Center
      • Columbus, Ohio, United States, 43205
        • Ohio State University Hospital East
      • Columbus, Ohio, United States, 43213
        • Mt. Carmel St. Ann Hospital
      • Dayton, Ohio, United States, 45459
        • Southview Medical Center
      • Hamilton, Ohio, United States, 45013
        • Fort Hamilton Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • West Chester, Ohio, United States, 45069
        • West Chester Hospital
    • Pennsylvania
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong County Memorial Hospital
      • Lewisburg, Pennsylvania, United States, 17837
        • Evangelical Community Hospital
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC McKeesport
      • Meadville, Pennsylvania, United States, 16335
        • Meadville Medical Center
      • Monongahela, Pennsylvania, United States, 15063
        • Monongahela Valley Hospital
      • Philadelphia, Pennsylvania, United States, 19152
        • Nazareth Hospital
      • York, Pennsylvania, United States, 17403
        • Memorial Hospital

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient population includes inpatients and outpatients undergoing diagnostic cardiac catheterization for suspected coronary artery disease (CAD) at hospitals without SOS.

Description

Inclusion Criteria:

Patient inclusion criteria are:

Pre-catheterization

  1. must be undergoing diagnostic cardiac catheterization for suspected CAD
  2. be at least 18 years of age
  3. must not be pregnant (negative pregnancy test) or must not be of childbearing potential
  4. must be able to give informed consent. Post-catheterization
  5. coronary artery disease judged to be clinically and angiographically significant
  6. ability to perform PCI with equipment available at the local site (see below)
  7. procedure risk judged to be not high (see below)

Exclusion Criteria:

Patient exclusion criteria are:

Pre-catheterization

  1. inability to give informed consent
  2. ST-segment elevation myocardial infarction
  3. pregnancy Post-catheterization
  4. high likelihood of requiring a device not available at the hospitals without SOS (see below)
  5. no need for PCI
  6. need for coronary artery bypass surgery
  7. high procedural risk (see below)

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

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
Number of participants with adverse events
Time Frame: Thru Index or Transfer Hospital Discharge on average 24 hours
Thru Index or Transfer Hospital Discharge on average 24 hours

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

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.
  • Principal Investigator: Thomas Aversano, MD, Johns Hopkins University

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 (Actual)

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, 2011

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.
December 31, 2015

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.
March 1, 2016

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).
March 18, 2014

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.
May 13, 2014

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.
May 14, 2014

Study Record Updates

Last Update Posted (Actual)

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.
April 12, 2018

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.
April 10, 2018

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.
April 1, 2018

More Information

Terms related to this study

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_00046362

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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