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

Coronary Artery Disease Clinical Trial

— CPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137980
• Other study ID #: NA_00046362
• Status: Completed
• First received: March 18, 2014
• Last updated: April 10, 2018
• Start date: April 1, 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31390
• Est. completion date: March 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Disease
• Heart Attack
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Bayonne Medical Center	Bayonne	New Jersey
United States	Clara Maas Medical Center	Belleville	New Jersey
United States	Community Health and Wellness Center	Bryan	Ohio
United States	St. Agnes Hospital	Catonsville	Maryland
United States	University Hospital Geauga Medical Center	Chardon	Ohio
United States	Southern Maryland Hospital Center	Clinton	Maryland
United States	Mt. Carmel St. Ann Hospital	Columbus	Ohio
United States	Ohio State University Hospital East	Columbus	Ohio
United States	Southview Medical Center	Dayton	Ohio
United States	JFK Medical Center	Edison	New Jersey
United States	Trinitas Hospital	Elizabeth	New Jersey
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	Fort Hamilton Hospital	Hamilton	Ohio
United States	Crestwood Medical Center	Huntsville	Alabama
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	Evangelical Community Hospital	Lewisburg	Pennsylvania
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	Virtua West Jersey Hospital	Marlton	New Jersey
United States	UPMC McKeesport	McKeesport	Pennsylvania
United States	Meadville Medical Center	Meadville	Pennsylvania
United States	Monongahela Valley Hospital	Monongahela	Pennsylvania
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Licking Memorial Hospital	Newark	Ohio
United States	Raritan Bay Medical Center	Perth Amboy	New Jersey
United States	Nazareth Hospital	Philadelphia	Pennsylvania
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Shady Grove Adventist Hospital	Rockville	Maryland
United States	Somerset Medical Center	Somerville	New Jersey
United States	Overlook Hospital	Summit	New Jersey
United States	Holy Name Hospital	Teaneck	New Jersey
United States	Community Medical Center	Toms River	New Jersey
United States	West Chester Hospital	West Chester	Ohio
United States	Memorial Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Thru Index or Transfer Hospital Discharge on average 24 hours