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

NCT ID: NCT04636021

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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Conditions

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Corona Virus Infection

Keywords

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COVID-19 testing outpatient procedures

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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COVID-19 testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pinnacle Health Cardiovascular Institute

NETWORK

Sponsor Role lead

Responsible Party

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William Bachinsky MD

Director, Cardiovascular Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William Bachinsky, MD

Role: CONTACT

Phone: (717) 731-0101

Email: [email protected]

Facility Contacts

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William Bachinsky, MD

Role: primary

Other Identifiers

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UPMCP # 20-007

Identifier Type: -

Identifier Source: org_study_id