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

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

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

Study Overview

• Status: Unknown
• Conditions: Corona Virus Infection
• Intervention / Treatment: Diagnostic test: COVID-19 testing

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: William Bachinsky, MD; Phone Number: (717) 731-0101; Email: bachinskywb@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17011
      • Recruiting
      • UPMC Pinnacle Harrisburg
      • Contact: William Bachinsky, MD; Phone Number: 717-731-0101; Email: bachinskywb@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures	Through 30 day follow up period

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pinnacle Health Cardiovascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19 testing; outpatient procedures
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: UPMCP # 20-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes