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

Corona Virus Infection Clinical Trial

— RECIPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636021
• Other study ID #: UPMCP # 20-007
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Pinnacle Health Cardiovascular Institute
• Contact: William Bachinsky, MD
• Phone: (717) 731-0101
• Email: bachinskywb[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• COVID-19 testing
Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.

Locations

Country	Name	City	State
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pinnacle Health Cardiovascular Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures		Through 30 day follow up period
Secondary	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