Cardiovascular Risk Factors and Severe COVID-19. A Nationwide Registry-based Case-Control Study

July 27, 2022 updated by: Per Svensson, Karolinska Institutet

Cardiovascular Disease, Cardiovascular Risk Factors, Treatments and Severe COVID-19 Outcomes. A Nationwide Registry-based Case-Control Study

In this study we cross-reference several nationwide high-quality Swedish registers in order to study risk factors for severe Covid-19 outcomes.

Study Overview

Status

Active, not recruiting

Conditions

COVID-19

Intervention / Treatment

Detailed Description

In this nationwide, case-control study we cross-reference several detailed, high-quality Swedish registers in order to study risk factors associated with severe Covid-19 as well as different disease outcomes, with a focus on cardiovascular disease, chronic kidney disease, different treatments and socioeconomic factors. Cases are identified through the Swedish intensive care register (SIR) and controls through the Swedish population register (RTB). Further information on the study participants is gathered by linkage to registers on: prescribed drugs; history of in- and outpatient care; income, education and migration. Follow-up data such as future hospitalization and mortality will be gathered prospectively.

Study Type

Observational

Enrollment (Actual)

22784

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- - Stockholm, Sweden, 11883
    - Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 1,424 cases and 14,240 control subjects (first analysis june 2020) A total of 4684 cases and 46840 control subjects (july 2022)

Description

Inclusion Criteria:

Cases: Admitted to intensive care unit in Sweden and registered admission in the Swedish intensive care register (SIR) with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD10: U07.1). (cases)
Control subjects matched for age, gender,residency: For each case 10 controls matched for age, gender and district of residence will be identified by Statistics Sweden (SCB) in the Swedish population register (RTB).
Control subjects matched for age and gender: For each case 5 controls matched for age and gender will be identified by by Statistics Sweden (SCB) in the Swedish population register (RTB).

Exclusion Criteria:

No valid Swedish personal identity number (PIN)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Covid-19 Time Frame: 2020-03-01 to 2020-05-11	Admitted to ICU in Sweden with a main diagnosis of Covid-19 confirmed by laboratory testing (ICD 10: U07.1) and requring mechanical ventilation	2020-03-01 to 2020-05-11
Severe Covid-19 with pulmonary embolism Time Frame: 2020-03-01 to 2020-05-11	Admitted to ICU in Sweden with a diagnosis of Covid-19 confirmed by laboratory testing (ICD 10: U07.1) and a bidiagnosis of pulmonary embolism (ICD10:I26)	2020-03-01 to 2020-05-11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRRT(Continuous Renal Replacement Therapy) Time Frame: 2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring CRRT	2020-03-01 to 2020-05-11
ECMO (Extracorporeal Membrane Oxygenation ) Time Frame: 2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 requring ECMO	2020-03-01 to 2020-05-11
ICU Mortality Time Frame: 2020-03-01 to 2020-05-11	Number of participants admitted to ICU in Sweden with a verified diagnosis of Covid-19 with death occurring in ICU after admission	2020-03-01 to 2020-05-11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Svensson P, Hofmann R, Habel H, Jernberg T, Nordberg P. Association between cardiometabolic disease and severe COVID-19: a nationwide case-control study of patients requiring invasive mechanical ventilation. BMJ Open. 2021 Feb 17;11(2):e044486. doi: 10.1136/bmjopen-2020-044486.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

June 8, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria