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

Completed

• Conditions: Coronary Artery Disease; Heart Attack; Angina

• Registration Number: NCT02137980
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-04-01
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Primary Completion: 2015-12-31
• Study Completion: 2016-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31390

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (37)

Crestwood Medical Center; 🇺🇸 Huntsville, Alabama, United States

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States

Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

St. Agnes Hospital; 🇺🇸 Catonsville, Maryland, United States

Southern Maryland Hospital Center; 🇺🇸 Clinton, Maryland, United States

Frederick Memorial Hospital; 🇺🇸 Frederick, Maryland, United States

Baltimore Washington Medical Center; 🇺🇸 Glen Burnie, Maryland, United States

Meritus Medical Center; 🇺🇸 Hagerstown, Maryland, United States

Shady Grove Adventist Hospital; 🇺🇸 Rockville, Maryland, United States

Bayonne Medical Center; 🇺🇸 Bayonne, New Jersey, United States

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