NCT04636021

Brief Summary

Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 13, 2020

Last Update Submit

November 18, 2020

Conditions

Keywords

COVID-19 testingoutpatient procedures

Outcome Measures

Primary Outcomes (1)

  • Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures

    Through 30 day follow up period

Secondary Outcomes (1)

  • Patient perception of the effect of pre and post procedure COVID-19 testing on risk of contracting COVID-19 while hospitalized for an elective outpatient procedure.

    Through 30 day follow up period

Interventions

COVID-19 testingDIAGNOSTIC_TEST

Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective cardiac procedures in the time of COVID- 19

You may qualify if:

  • Outpatients undergoing non-emergent invasive cardiac diagnostic, cardiac interventional, peripheral diagnostic, peripheral interventional, structural heart interventional, electrophysiology diagnostic, ablation, or device implantation procedures

You may not qualify if:

  • Previous positive COVID-19 test result
  • Patients with symptoms concerning for COVID-19, including (but not limited to):
  • Fever \> 38˚C, shortness of breath and/or cough in greater severity from baseline, sore throat, anosmia / dysgeusia, vomiting/diarrhea within 24 hours prior to procedure
  • Emergent status including (but not limited to) acute coronary syndromes, acute limb ischemia, stroke, need of temporary pacemaker
  • Non-outpatient status including (but not limited to) patients evaluated in the hospital, observational unit, or emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17011, United States

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Interventions

COVID-19 Testing

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

William Bachinsky, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiovascular Research

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations