Restoring Non-Emergent Cardiovascular Care in the Peri- C... | NCT04636021

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

NCT04636021

Sponsor

Pinnacle Health Cardiovascular Institute

Status

Unknown status

Last Update Posted

Nov 19, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Corona Virus Infection

Interventions

COVID-19 testing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2020

Last Update Posted Date

Nov 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 testing	Diagnostic Test	Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William Bachinsky, MD	Contact	(717) 731-0101		bachinskywb@upmc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Pinnacle Harrisburg	Recruiting	Harrisburg	Pennsylvania	17011	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000086742	COVID-19 Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided