CClinicalTrials.gg
Status unknownNCT04636021RECIPEUpdated Nov 19, 2020

Restoring Non-Emergent Cardiovascular Care in the Peri- COVID-19 Era

An observational study in Corona Virus Infection, sponsored by Pinnacle Health Cardiovascular Institute. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Pinnacle Health Cardiovascular Institute · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Sex
All
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Study summary

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

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Conditions studied

  • Corona Virus Infection

Keywords

  • COVID-19 testing
  • outpatient procedures
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Pinnacle Health Cardiovascular Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • Diagnostic testCOVID-19 testing

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

06

What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: Through 30 day follow up period

07

Study locations

1 of 1 sites recruiting
  • UPMC Pinnacle Harrisburg
    Harrisburg, Pennsylvania 17011, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04636021
Lead sponsor
Pinnacle Health Cardiovascular Institute
Responsible party
William Bachinsky MD (Director, Cardiovascular Research, Pinnacle Health Cardiovascular Institute) — Principal investigator
First posted
Nov 19, 2020
Start date
Aug 1, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Nov 19, 2020

Study contacts

William Bachinsky, MD
Contact
bachinskywb@upmc.edu
(717) 731-0101

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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