NCT05021575

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
839,678

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

August 25, 2021

Conditions

Keywords

cardiovascular diseasesCOVID-19health care systemcardiovascular mortalityhospitalizationsoutpatient carecardiovascular interventions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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

    2 years

  • In-hospital mortality rates in Lithuania in 2019 and 2020

    2 years

  • Comparison of distribution of death places in Lithuania in 2019 and 2020

    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

    3 months

Study Arms (2)

2020

Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2020.

Other: Data collection on outpatient careOther: Data collection on hospitalisationOther: Data collection on cardiovascular mortalityOther: 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.

Other: Data collection on outpatient careOther: Data collection on hospitalisationOther: Data collection on cardiovascular mortalityOther: Data collection of patients presenting to the tertiary care centre with acute coronary syndrome

Interventions

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: 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.

20192020

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.

20192020

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.

20192020

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.

20192020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Hygiene

Vilnius, Lithuania

Location

National Health Insurance Fund under the Ministry of Health, Lithuania

Vilnius, Lithuania

Location

Vilnius University

Vilnius, Lithuania

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher and Professor in Clinic of Cardiac and Vascular Diseases, Centre of Cardiology and Angiology, Vilnius University; Senior cardiologist in Unit of Stress testing, Vilnius University Hospital Santaros Klinikos

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 25, 2021

Study Start

June 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations