Corona Virus InfectionRECIPENCT04636021
Restoring Non-Emergent Cardiovascular Care in the Peri- COVID-19 Era
An observational study of Corona Virus Infection, run by Pinnacle Health Cardiovascular Institute at 1 site in United States.
Trial summary
Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- COVID-19 testing
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 30 Jun 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing elective cardiac procedures in the time of COVID- 19
Who may be able to join
- Outpatients undergoing non-emergent invasive cardiac diagnostic, cardiac interventional, peripheral diagnostic, peripheral interventional, structural heart interventional, electrophysiology diagnostic, ablation, or device implantation procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17011
William Bachinsky, MD, 717-731-0101, bachinskywb@upmc.edu
About this study
Official title: 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
- Conditions
- Corona Virus Infection
- Being tested
- COVID-19 testing
- Keywords
- COVID-19 testing, outpatient procedures
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 testingDiagnostic test
Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures
Measured: 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.
Measured: Through 30 day follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Pinnacle Health Cardiovascular Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, William Bachinsky MD, Pinnacle Health Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636021
- Sponsor's protocol ID
- UPMCP # 20-007
- Acronym
- RECIPE
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Non-Emergent Cardiovascular Care in the Peri-COVID 19 Era
- ClinicalTrials.gov ID
- NCT04636021
- Acronym / sponsor ID
- RECIPE / UPMCP # 20-007
- Conditions
- Corona Virus Infection
- Keywords
- COVID-19 testing, outpatient procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pinnacle Health Cardiovascular InstituteResearch network
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective cardiac procedures in the time of COVID- 19
Key inclusion criteria (1 listed)
- Outpatients undergoing non-emergent invasive cardiac diagnostic, cardiac interventional, peripheral diagnostic, peripheral interventional, structural heart interventional, electrophysiology diagnostic, ablation, or device implantation procedures
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 testingPre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures. | Diagnostic test | – |
Primary outcome
Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures
Time frame: Through 30 day follow up period
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection, run by Pinnacle Health Cardiovascular Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Bachinsky, MD ((717) 731-0101, bachinskywb@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures (time frame: Through 30 day follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.