Information & documents for professionals
Does your center want to participate? Join us! Please see the infographic below on which steps you have to take. Click here to view the infographic intended for Dutch hospitals only.
A pneumonia of unknown cause occurring in Wuhan, China was reported on 31 December 2019 to the WHO Country Office in China. A new coronavirus virus called SARS-CoV-2 turned out to be the cause of the outbreak. This virus can cause the disease COVID-19. Due to rapid spreading of the virus, the WHO declared the outbreak a Public Health Emergency of International Concern on 30 January 2020. Since 11 March 2020, COVID-19 is considered to be a pandemic.
From emerging literature on the clinical disease manifestation of COVID-19, fever and respiratory symptoms seem most common. However, a significant number of patients develops cardiovascular complications. Furthermore, patients with pre-existent cardiovascular comorbidities seem to have an increased chance of developing serious complications of COVID-19. Insufficient evidence is currently available to guide monitoring of cardiovascular complications and treatment decisions in COVID-19 patients with a history of cardiovascular disease.
CAPACITY is a registry of patients with COVID-19 including cardiovascular risk and complications. 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.
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 establishment and 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.
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Study Protocol
Study protocol (English only):
REDCap
REDCap codebook (English only):
Data Quality Checks (English only):
Standard Operating Procedure REDCap Uploading Images (English only):
REDCap account request formulier (English only):
Operating Procedures
Standard Operating Procedure (SOP) Study ID’s (English or Dutch):
Operating Procedure sharing data with ISARIC (English only)
Patient Information
Template Patient Information Form (PIF) (English, Dutch, Portuguese or Italian):
Template Opt-Out for patients (English, Dutch, Portuguese or Italian):
Other
CAPACITY one pager (English only):
Please contact us for the Data Transfer Agreement (DTA).
UK Study Protocol
UK Data Dictionary
UK Capacity Frequently Asked Questions
Together we are investigating the role cardiovascular disease in the COVID-19 pandemic. We sincerely invite our international colleagues and researchers to apply for data access or to join efforts that are already ongoing. The following six research questions have formulated by the Data Access Committee and are being assessed:
- What is the incidence and pattern of cardiovascular complications in patients with COVID-19?
- Does the clinical presentation of COVID-19 differ between patients with and without a history of cardiovascular disease?
- What is the extent of cardiac damage in patients with COVID-19?
- Do patients with COVID-19 and cardiovascular risk factors or underlying cardiovascular disease have a worse disease course? If this is the case, which cardiovascular risk factors and types of cardiovascular diseases are especially associated with a poor outcome?
- Does the use of medication that influence ACE-2 expression worsen the course of COVID-19 (ACEi, ARBs, NSAIDs and thiazolidinediones)?
- What is the effect of therapy for COVID-19 on patients with cardiac complications or underlying cardiovascular disease? E.g. chloroquine and effect on QT-interval.
- Oral anticoagulation and COVID-19 outcome – Disease modifiers
- Sex differences in COVID-19
- Effect of diabetes on COVID-19 cardiovascular complications
- Acute cardiac injury and ACS in COVID-19
- Arrhythmias and conduction disorders in COVID-19
- Non-invasive 12-lead ECG analysis in patients with COVID-19
- Disease-specific ECG features in patients with COVID-19
Contact us to join already ongoing projects
How to apply for data access:
- First check the overview of applications to avoid overlap with an existing project.
- Start your application by filling in the application form via https://podium.bbmri.nl. By sending this form the request will go to info@capacity-covid.eu
- To gain access, this form including your research questions, required data and/or samples, financing, and timeline of the research must be submitted
- Make your data selection using this specific CAPACITY REDCap codebook. Please select your variables with corresponding variable names and labels. This file must be submitted as well alongside the application form using https://podium.bbmri.nl.
- The submitted application will be reviewed within one week by the CAPACITY Data Access Committee.
- Once an application is approved, CAPACITY will prepare a Data Transfer Agreement (DTA) for you to sign.
- Data will be released after signing the DTA.
- The data will be released in a digital research environment (the CAPACITY workspace).
- For further information regarding data access see this file.
FAQs
For more information, click on the questions below or contact us.
All patients who have tested positive or are highly suspected of COVID-19 and are admitted to the hospital. Patients who do not opt-out can be included in the registry.
This research is observational, data acquired during routine clinical care will be registered. Data of the admission will be collected with standardized Data Collection Instruments in REDCap. In addition to the ISARIC-WHO CRF, the CAPACITY REDCap project has multiple additional Data Collection Instruments, including: cardiac history and cardiovascular risk factors, cardiac biomarkers, ECG, echocardiography, cardiac MRI, invasive cardiac procedures, cardiac complications during admission and cardiac outcome after 7 and 30 days.
Data will be stored secured and de-identified by using a unique study code in a REDCap registry.
