COVID-19; Cardiovascular DiseasesCAPACITY-COVIDNCT04325412
Cardiac complicAtions in Patients With SARS Corona vIrus 2 (COVID-19) regisTrY
An observational study of COVID-19; Cardiovascular Diseases, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19; Cardiovascular Diseases
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2020to 23 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.
Who may be able to join
- Highly suspected/confirmed infection with SARS-CoV-2
Who cannot join
- Patients that opt-out
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Marijke Linschoten, MD, +31 (0)88 755 5555, m.p.m.linschoten@umcutrecht.nl
About this study
Official title: Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY
CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.
Read the detailed description
The aim of CAPACITY is to collect data regarding the cardiovascular history, diagnostic information and occurrence of cardiovascular complications in COVID-19 patients. By collecting this information in a standardized manner, CAPACITY can aid in providing more insight in (1) the incidence of cardiovascular complications in patients with COVID-19, and (2) the vulnerability and clinical course of COVID-19 in patients with an underlying cardiovascular disease.
The CAPACITY extension to the ISARIC-WHO CRF consists of additional data collection instruments for:
- cardiac history and cardiovascular risk factors
- prior use of cardiac medication or NSAIDs
- electrocardiography (ECG)
- echocardiography
- cardiac MRI
- invasive cardiac procedures
- cardiac complications
- cardiac biomarkers
- cardiac outcome during admission
- Conditions
- COVID-19; Cardiovascular Diseases
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cardiovascular complications in patients with COVID-19
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Mar 2020
- Primary completion23 Mar 2021 (estimated)
- Study completion23 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19; Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. F.W. Asselbergs, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325412
- Sponsor's protocol ID
- 20-161/C
- Acronym
- CAPACITY-COVID
- Status last verified
- Nov 2020
- First submitted
- 25 Mar 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Henkens MTHM, Raafs AG, Verdonschot JAJ, Linschoten M, van Smeden M, Wang P, van der Hooft BHM, Tieleman R, Janssen MLF, Ter Bekke RMA, Hazebroek MR, van der Horst ICC, Asselbergs FW, Magdelijns FJH, Heymans SRB; CAPACITY-COVID collaborative consortium. Age is the main determinant of COVID-19 related in-hospital mortality with minimal impact of pre-existing comorbidities, a retrospective cohort study. BMC Geriatr. 2022 Mar 5;22(1):184. doi: 10.1186/s12877-021-02673-1.
PubMed 35247983
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY
- ClinicalTrials.gov ID
- NCT04325412
- Acronym / sponsor ID
- CAPACITY-COVID / 20-161/C
- Conditions
- COVID-19; Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 23 Mar 2021 (estimated)
- Study completion
- 23 Jun 2021 (estimated)
- First posted
- 27 Mar 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.
CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.
Detailed description
The aim of CAPACITY is to collect data regarding the cardiovascular history, diagnostic information and occurrence of cardiovascular complications in COVID-19 patients. By collecting this information in a standardized manner, CAPACITY can aid in providing more insight in (1) the incidence of cardiovascular complications in patients with COVID-19, and (2) the vulnerability and clinical course of COVID-19 in patients with an underlying cardiovascular disease.
The CAPACITY extension to the ISARIC-WHO CRF consists of additional data collection instruments for:
- cardiac history and cardiovascular risk factors
- prior use of cardiac medication or NSAIDs
- electrocardiography (ECG)
- echocardiography
- cardiac MRI
- invasive cardiac procedures
- cardiac complications
- cardiac biomarkers
- cardiac outcome during admission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.
Key inclusion criteria (1 listed)
- Highly suspected/confirmed infection with SARS-CoV-2
Key exclusion criteria (1 listed)
- Patients that opt-out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of cardiovascular complications in patients with COVID-19
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 35247983Henkens MTHM, Raafs AG, Verdonschot JAJ, Linschoten M, van Smeden M, Wang P, van der Hooft BHM, Tieleman R, Janssen MLF, Ter Bekke RMA, Hazebroek MR, van der Horst ICC, Asselbergs FW, Magdelijns FJH, Heymans SRB; CAPACITY-COVID collaborative consortium. Age is the main determinant of COVID-19 related in-hospital mortality with minimal impact of pre-existing comorbidities, a retrospective cohort study. BMC Geriatr. 2022 Mar 5;22(1):184. doi: 10.1186/s12877-021-02673-1.
- All study documents can be found on this website.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 COVID-19; Cardiovascular Diseases, run by UMC Utrecht at 1 site in Netherlands.
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 1 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 10 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 Netherlands. 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 Folkert W. Asselbergs, MD, PhD (+31 (0) 88 755 5555, f.w.asselbergs@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cardiovascular complications in patients with COVID-19 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325412, which also lists 1 linked publication.
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 10 Nov 2020.