Cardiovascular DiseasesCOVID-COR-LTNCT05021575
Effects of COVID-19 Pandemic on a Health Care System: Case Study of the CirculatORy System in LiThuania
An observational study of Cardiovascular Diseases, run by Vilnius University at 3 sites in Lithuania.
Trial summary
Coronavirus disease of 2019 (COVID-19) affected the health care systems all around the world. The collateral damage of the pandemic on the cardiovascular (CV) care and CV mortality has been noticed and reported early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Data collection on outpatient care, Data collection on hospitalisation and Data collection on cardiovascular mortality
- How many people
- 839,678 participants
- Where
- 3 sitesLithuania
- Study dates
- 1 Jun 2020to 31 Dec 2020
- 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: Adult patients (≥18 years old) included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020 or in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.
Who may be able to join
- ≥18 years old adult patients
- Included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020
- Included in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.
Who cannot join
- Cases, when sex was not available were excluded from sex differences analysis.
- Death certificates where place of death was unspecified were excluded from death place analysis
Trial locations and contacts
3 sites in 1 country.
Lithuania3 sites
Institute of Hygiene
Vilnius
National Health Insurance Fund under the Ministry of Health, Lithuania
Vilnius
Vilnius University
Vilnius
About this study
Official title: Effects of COVID-19 Pandemic on Personal and Public Health and Functioning of Health Care System: Case Study of the CirculatORy System in LiThuania
Coronavirus disease of 2019 (COVID-19) affected the health care systems all around the world. The collateral damage of the pandemic on the cardiovascular (CV) care and CV mortality has been noticed and reported early. In Lithuania, first quarantine measurements were introduced on 16th March and lifted on 16th June of 2020, limiting contact appointments to urgent care only. This led to a substantial proportion of routine cardiovascular appointments, diagnostic and therapeutic procedures being cancelled and greatly limited the availability of cardiovascular care. The prognostic impact of this has not been appropriately analysed. Also, comprehensive analyses of the changes in national CV services, including outpatient care and hospitalisations and CV mortality, during different periods of the pandemic (during first and second waves and in between) are scarce. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality
Read the detailed description
COVID-19 pandemic has greatly affected the world and changed health care in almost every country. During the spring of 2020, first pandemic wave was of different scale in different countries. In countries affected by the virus the most, a majority of the studies focused on the direct impact of COVID-19 on community health. It was noticed promptly that the novel virus is especially high-risk for patients with cardiovascular comorbidities. Furthermore, the collateral damage of COVID-19 pandemic on the provision of cardiovascular (CV) care and cardiovascular mortality was also reported early in several nationwide and selected cohort studies. The research was mostly focused on acute cardiovascular conditions; changes in hospital admissions and early mortality after myocardial infarction were also often analysed. Meanwhile, a substantial proportion of routine appointments, diagnostic and therapeutic procedures was cancelled. Data on the changes in total national CV services, including out- and in-patient health care facilities, acute and chronic conditions, during the outbreak, between the two pandemic waves and onwards are scarce. First case of COVID-19 in Lithuania was confirmed on 28th February 2020. First nationwide quarantine was introduced by Lithuanian government on 16th March and ended on 16th June. In that period, although Lithuania was reported among the least affected countries according to World Health Organization - 1 773 COVID-19 cases were recorded and 86 patients (of whom 10 patients died from other causes after testing positive for SARS-CoV-2) had died before the end of quarantine, Lithuanian government limited contact appointments to urgent conditions only. The utmost efforts to provide triage, follow-up care by telephone call and e-prescriptions were recommended. This greatly affected availability of cardiovascular care. The second pandemic wave in Lithuania was substantially more severe. Consequently, the second nationwide quarantine was implemented on 7th November, 2020. Contact appointments were not limited by the government; however, the scope of CV care was again negatively affected, mostly by the strained health care system.
We analysed the indirect impact of the COVID-19 pandemic in a country, which was hit by two very different pandemic waves. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality
- Conditions
- Cardiovascular Diseases
- Being tested
- Data collection on outpatient care, Data collection on hospitalisation, Data collection on cardiovascular mortality, Data collection of patients presenting to the tertiary care centre with acute coronary syndrome
- Keywords
- cardiovascular diseases, COVID-19, health care system, cardiovascular mortality, hospitalizations, outpatient care, cardiovascular interventions
- Medical subject headings
- Cardiovascular Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on outpatient careOther
Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.
Outpatient data related to cardiovascular diseases (CVD) were collected as described:
- data on visits were collected using ICD-10 codes I00-I99 and other CVD related codes (e.g., certain Z, Q codes, J81.0, R57.0)
- data were collected from CVD prevention program
- data on interventional cardiology were collected from day care facility regardless of the diagnosis.
Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded.
Data collection on hospitalisationOther
Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.
Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code.
Data collection on cardiovascular mortalityOther
Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year. Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range. Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
Data collection of patients presenting to the tertiary care centre with acute coronary syndromeOther
Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year. The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.
| Study group | Role | What they receive |
|---|---|---|
| 2020 | Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2020. Receives: Other: Data collection on outpatient care; Other: Data collection on hospitalisation; Other: Data collection on cardiovascular mortality; Other: Data collection of patients presenting to the tertiary care centre with acute coronary syndrome | |
| 2019 | Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2019. Receives: Other: Data collection on outpatient care; Other: Data collection on hospitalisation; Other: Data collection on cardiovascular mortality; Other: Data collection of patients presenting to the tertiary care centre with acute coronary syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
Measured: 2 years
Number of cardiovascular hospitalisations in Lithuania in 2019 and 2020
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
Measured: 2 years
Cardiovascular mortality rates in Lithuania in 2019 and 2020
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
Measured: 2 years
Secondary outcomes (4)
Evaluation of sex and age differences in changes of CV care provision and CV deaths during the pandemic and comparison between 2019 and 2020
Comparison of cardiovascular outpatient care visits, hospitalisation numbers and cardiovascular mortality rates between men and women and between different age groups.
Measured: 2 years
In-hospital mortality rates in Lithuania in 2019 and 2020
Comparison of mortality rate in hospitalised patients in Lithuania between 2019 and 2020
Measured: 2 years
Comparison of distribution of death places in Lithuania in 2019 and 2020
Assessing the differences in the death places written in the death certificates of the people deceased from cardiovascular causes between 2019 and 2020
Measured: 2 years
Comparison of all-cause mortality during the hospital stay and at 3 months of follow-up in patients presenting to a tertiary care centre with acute coronary syndrome during the first quarantine in 2020 and in a corresponding period of 2019
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 839,678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Hygiene, Lithuania, National Health Insurance Fund under the Ministry of Health, Lithuania, Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Jelena Čelutkienė, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021575
- Sponsor's protocol ID
- S-COV-20-27
- Other IDs
- S-COV-20-27, 2020/8-1247-730
- Acronym
- COVID-COR-LT
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celutkiene J, Cerlinskaite-Bajore K, Bajoras V, Visinskiene R, Lizaitis M, Budrys P, Buivydas R, Gurevicius R, Serpytis P, Davidavicius G. Collateral effect of the COVID-19 pandemic on cardiology service provision and cardiovascular mortality in a population-based study: COVID-COR-LT. Clin Res Cardiol. 2022 Oct;111(10):1130-1146. doi: 10.1007/s00392-022-02033-y. Epub 2022 May 12.
PubMed 35552504
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COVID-19 Pandemic on Personal and Public Health and Functioning of Health Care System: Case Study of the CirculatORy System in LiThuania
- ClinicalTrials.gov ID
- NCT05021575
- Acronym / sponsor ID
- COVID-COR-LT / S-COV-20-27
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiovascular diseases, COVID-19, health care system, cardiovascular mortality, hospitalizations, outpatient care, cardiovascular interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839,678 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Institute of Hygiene, Lithuania, National Health Insurance Fund under the Ministry of Health, Lithuania, Vilnius University Hospital Santaros Klinikos
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Aug 2021 (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.
Coronavirus disease of 2019 (COVID-19) affected the health care systems all around the world. The collateral damage of the pandemic on the cardiovascular (CV) care and CV mortality has been noticed and reported early. In Lithuania, first quarantine measurements were introduced on 16th March and lifted on 16th June of 2020, limiting contact appointments to urgent care only. This led to a substantial proportion of routine cardiovascular appointments, diagnostic and therapeutic procedures being cancelled and greatly limited the availability of cardiovascular care. The prognostic impact of this has not been appropriately analysed. Also, comprehensive analyses of the changes in national CV services, including outpatient care and hospitalisations and CV mortality, during different periods of the pandemic (during first and second waves and in between) are scarce. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality
Detailed description
COVID-19 pandemic has greatly affected the world and changed health care in almost every country. During the spring of 2020, first pandemic wave was of different scale in different countries. In countries affected by the virus the most, a majority of the studies focused on the direct impact of COVID-19 on community health. It was noticed promptly that the novel virus is especially high-risk for patients with cardiovascular comorbidities. Furthermore, the collateral damage of COVID-19 pandemic on the provision of cardiovascular (CV) care and cardiovascular mortality was also reported early in several nationwide and selected cohort studies. The research was mostly focused on acute cardiovascular conditions; changes in hospital admissions and early mortality after myocardial infarction were also often analysed. Meanwhile, a substantial proportion of routine appointments, diagnostic and therapeutic procedures was cancelled. Data on the changes in total national CV services, including out- and in-patient health care facilities, acute and chronic conditions, during the outbreak, between the two pandemic waves and onwards are scarce. First case of COVID-19 in Lithuania was confirmed on 28th February 2020. First nationwide quarantine was introduced by Lithuanian government on 16th March and ended on 16th June. In that period, although Lithuania was reported among the least affected countries according to World Health Organization - 1 773 COVID-19 cases were recorded and 86 patients (of whom 10 patients died from other causes after testing positive for SARS-CoV-2) had died before the end of quarantine, Lithuanian government limited contact appointments to urgent conditions only. The utmost efforts to provide triage, follow-up care by telephone call and e-prescriptions were recommended. This greatly affected availability of cardiovascular care. The second pandemic wave in Lithuania was substantially more severe. Consequently, the second nationwide quarantine was implemented on 7th November, 2020. Contact appointments were not limited by the government; however, the scope of CV care was again negatively affected, mostly by the strained health care system.
We analysed the indirect impact of the COVID-19 pandemic in a country, which was hit by two very different pandemic waves. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2020 | – | Other: Data collection on outpatient care, Other: Data collection on hospitalisation, Other: Data collection on cardiovascular mortality, Other: Data collection of patients presenting to the tertiary care centre with acute coronary syndromeData on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2020. |
| 2019 | – | Other: Data collection on outpatient care, Other: Data collection on hospitalisation, Other: Data collection on cardiovascular mortality, Other: Data collection of patients presenting to the tertiary care centre with acute coronary syndromeData on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020 or in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.
Key inclusion criteria (3 listed)
- ≥18 years old adult patients
- Included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020
- Included in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.
Key exclusion criteria (2 listed)
- Cases, when sex was not available were excluded from sex differences analysis.
- Death certificates where place of death was unspecified were excluded from death place analysis
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 |
|---|---|---|
| Data collection on outpatient careOutpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Outpatient data related to cardiovascular diseases (CVD) were collected as described: 1. data on visits were collected using ICD-10 codes I00-I99 and other CVD related codes (e.g., certain Z, Q codes, J81.0, R57.0) 2. data were collected from CVD prevention program 3. data on interventional cardiology were collected from day care facility regardless of the diagnosis. Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded. | Other | 2019, 2020 |
| Data collection on hospitalisationHospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code. | Other | 2019, 2020 |
| Data collection on cardiovascular mortalityData on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year. Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range. Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded. | Other | 2019, 2020 |
| Data collection of patients presenting to the tertiary care centre with acute coronary syndromeDemographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year. The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed. | Other | 2019, 2020 |
Primary outcome
Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020
Time frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
Number of cardiovascular hospitalisations in Lithuania in 2019 and 2020
Time frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
Cardiovascular mortality rates in Lithuania in 2019 and 2020
Time frame: 2 years
Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
4 secondary outcomes
Evaluation of sex and age differences in changes of CV care provision and CV deaths during the pandemic and comparison between 2019 and 2020
Time frame: 2 years
In-hospital mortality rates in Lithuania in 2019 and 2020
Time frame: 2 years
Comparison of distribution of death places in Lithuania in 2019 and 2020
Time frame: 2 years
Comparison of all-cause mortality during the hospital stay and at 3 months of follow-up in patients presenting to a tertiary care centre with acute coronary syndrome during the first quarantine in 2020 and in a corresponding period of 2019
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 35552504Celutkiene J, Cerlinskaite-Bajore K, Bajoras V, Visinskiene R, Lizaitis M, Budrys P, Buivydas R, Gurevicius R, Serpytis P, Davidavicius G. Collateral effect of the COVID-19 pandemic on cardiology service provision and cardiovascular mortality in a population-based study: COVID-COR-LT. Clin Res Cardiol. 2022 Oct;111(10):1130-1146. doi: 10.1007/s00392-022-02033-y. Epub 2022 May 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Vilnius University at 3 sites in Lithuania.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Lithuania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020 (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT05021575, 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 31 Aug 2021.