Recruiting

Observational Study

Sponsor:

Pinnacle Health Cardiovascular Institute

Code:

NCT04636021

Conditions

Corona Virus Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

COVID-19 testing

Study Details

Brief summary:

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

Conditions

Corona Virus Infection

Study ID

NCT04636021

Start date

Aug 1, 2020

Status verified date

Nov, 2020

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

COVID-19 testing

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

Primary outcome measure

  • Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures [ Time Frame: Through 30 day follow up period ]

Central Contacts and Locations

Central contacts

William Bachinsky, MD

(717) 731-0101bachinskywb@upmc.edu

Locations

UPMC Pinnacle Harrisburg

Recruiting

Harrisburg, Pennsylvania, United States, 17011

Contacts

William Bachinsky, MD

717-731-0101bachinskywb@upmc.edu

More Information

Sponsor

Pinnacle Health Cardiovascular Institute

Last update posted

Nov 19, 2020

Last verified

Nov, 2020

Keywords

  • COVID-19 testing
  • outpatient procedures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pinnacle Health Cardiovascular Institute on 2020-11-19.