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

NCT ID: NCT02137980

Last Updated: 2018-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-01

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Heart Attack Angina

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Aversano, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Crestwood Medical Center

Huntsville, Alabama, United States

Site Status

Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

St. Agnes Hospital

Catonsville, Maryland, United States

Site Status

Southern Maryland Hospital Center

Clinton, Maryland, United States

Site Status

Frederick Memorial Hospital

Frederick, Maryland, United States

Site Status

Baltimore Washington Medical Center

Glen Burnie, Maryland, United States

Site Status

Meritus Medical Center

Hagerstown, Maryland, United States

Site Status

Shady Grove Adventist Hospital

Rockville, Maryland, United States

Site Status

Bayonne Medical Center

Bayonne, New Jersey, United States

Site Status

Clara Maas Medical Center

Belleville, New Jersey, United States

Site Status

JFK Medical Center

Edison, New Jersey, United States

Site Status

Trinitas Hospital

Elizabeth, New Jersey, United States

Site Status

Virtua West Jersey Hospital

Marlton, New Jersey, United States

Site Status

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States

Site Status

Riverview Medical Center

Red Bank, New Jersey, United States

Site Status

Somerset Medical Center

Somerville, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

Holy Name Hospital

Teaneck, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

Community Health and Wellness Center

Bryan, Ohio, United States

Site Status

University Hospital Geauga Medical Center

Chardon, Ohio, United States

Site Status

Ohio State University Hospital East

Columbus, Ohio, United States

Site Status

Mt. Carmel St. Ann Hospital

Columbus, Ohio, United States

Site Status

Southview Medical Center

Dayton, Ohio, United States

Site Status

Fort Hamilton Hospital

Hamilton, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

West Chester Hospital

West Chester, Ohio, United States

Site Status

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, United States

Site Status

Evangelical Community Hospital

Lewisburg, Pennsylvania, United States

Site Status

UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

Meadville Medical Center

Meadville, Pennsylvania, United States

Site Status

Monongahela Valley Hospital

Monongahela, Pennsylvania, United States

Site Status

Nazareth Hospital

Philadelphia, Pennsylvania, United States

Site Status

Memorial Hospital

York, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00046362

Identifier Type: -

Identifier Source: org_study_id

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