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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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

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

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

Johns Hopkins University

Investigators

  • 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)

April 1, 2011

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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