Clinical trial NCT02137980: Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
Official title: Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Heart Attack
Angina
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 31390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Thru Index or Transfer Hospital Discharge on average 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Crestwood Medical Center
state: Alabama
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Hopkins Bayview Medical Center
state: Maryland
city: Catonsville
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Clinton
country: United States
facility: Southern Maryland Hospital Center
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Glen Burnie
country: United States
facility: Baltimore Washington Medical Center
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Medical Center
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Bayonne
country: United States
facility: Bayonne Medical Center
state: New Jersey
city: Belleville
country: United States
facility: Clara Maas Medical Center
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Elizabeth
country: United States
facility: Trinitas Hospital
state: New Jersey
city: Marlton
country: United States
facility: Virtua West Jersey Hospital
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Bryan
country: United States
facility: Community Health and Wellness Center
state: Ohio
city: Chardon
country: United States
facility: University Hospital Geauga Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital East
state: Ohio
city: Columbus
country: United States
facility: Mt. Carmel St. Ann Hospital
state: Ohio
city: Dayton
country: United States
facility: Southview Medical Center
state: Ohio
city: Hamilton
country: United States
facility: Fort Hamilton Hospital
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: West Chester
country: United States
facility: West Chester Hospital
state: Ohio
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: Lewisburg
country: United States
facility: Evangelical Community Hospital
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: Meadville
country: United States
facility: Meadville Medical Center
state: Pennsylvania
city: Monongahela
country: United States
facility: Monongahela Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Nazareth Hospital
state: Pennsylvania
city: York
country: United States
facility: Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Thomas Aversano, MD
role: PRINCIPAL_INVESTIGATOR
References: