NCT02137980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

4.8 years

First QC Date

March 18, 2014

Last Update Submit

April 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Thru Index or Transfer Hospital Discharge on average 24 hours

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Pre-catheterization
  • must be undergoing diagnostic cardiac catheterization for suspected CAD
  • be at least 18 years of age
  • must not be pregnant (negative pregnancy test) or must not be of childbearing potential
  • must be able to give informed consent. Post-catheterization
  • coronary artery disease judged to be clinically and angiographically significant
  • ability to perform PCI with equipment available at the local site (see below)
  • procedure risk judged to be not high (see below)

You may not qualify if:

  • Pre-catheterization
  • inability to give informed consent
  • ST-segment elevation myocardial infarction
  • pregnancy Post-catheterization
  • high likelihood of requiring a device not available at the hospitals without SOS (see below)
  • no need for PCI
  • need for coronary artery bypass surgery
  • high procedural risk (see below)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Crestwood Medical Center

Huntsville, Alabama, 35801, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Hopkins Bayview Medical Center

Baltimore, Maryland, 21044, United States

Location

St. Agnes Hospital

Catonsville, Maryland, 21229, United States

Location

Southern Maryland Hospital Center

Clinton, Maryland, 20735, United States

Location

Frederick Memorial Hospital

Frederick, Maryland, 21701, United States

Location

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

Meritus Medical Center

Hagerstown, Maryland, 21742, United States

Location

Shady Grove Adventist Hospital

Rockville, Maryland, 20850, United States

Location

Bayonne Medical Center

Bayonne, New Jersey, 07002, United States

Location

Clara Maas Medical Center

Belleville, New Jersey, 07109, United States

Location

JFK Medical Center

Edison, New Jersey, 08818, United States

Location

Trinitas Hospital

Elizabeth, New Jersey, 07207, United States

Location

Virtua West Jersey Hospital

Marlton, New Jersey, 08053, United States

Location

Raritan Bay Medical Center

Perth Amboy, New Jersey, 08861, United States

Location

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

Holy Name Hospital

Teaneck, New Jersey, 07666, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Community Health and Wellness Center

Bryan, Ohio, 43506, United States

Location

University Hospital Geauga Medical Center

Chardon, Ohio, 44024, United States

Location

Ohio State University Hospital East

Columbus, Ohio, 43205, United States

Location

Mt. Carmel St. Ann Hospital

Columbus, Ohio, 43213, United States

Location

Southview Medical Center

Dayton, Ohio, 45459, United States

Location

Fort Hamilton Hospital

Hamilton, Ohio, 45013, United States

Location

Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

West Chester Hospital

West Chester, Ohio, 45069, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

Evangelical Community Hospital

Lewisburg, Pennsylvania, 17837, United States

Location

UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

Meadville Medical Center

Meadville, Pennsylvania, 16335, United States

Location

Monongahela Valley Hospital

Monongahela, Pennsylvania, 15063, United States

Location

Nazareth Hospital

Philadelphia, Pennsylvania, 19152, United States

Location

Memorial Hospital

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Thomas Aversano, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

May 14, 2014

Study Start

April 1, 2011

Primary Completion

December 31, 2015

Study Completion

March 1, 2016

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations