Characteristics and Predictors of Early and Late Cardiovascular Complications of Covid-19 Patients - the PoLoCOV-Study (Polish LONG-COVID Cardiovascular Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,900
- Locations
- 1
- Primary Endpoint
- Early and Late COVID-19 cardio-vascular complications
Study Overview
Brief Summary
Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection. Patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome and as well as many other complications.
The vast majority of COVID-19 patients remaining in isolation/quarantine, due to the mild course of the disease, do not require hospitalization. In this group of patients, the course of COVID-19 is very different - from asymptomatic patients to very severe and long lasting symptoms also with a decrease in saturation.
There are many studies describing the course and complications of patients hospitalized due to COVID-19. There is little published data on how non-hospitalized patients get sick and what are the early and late complications of SARS-CoV-2 infection. In addition, many patients remain ill even many months after COVID-19, entering what is known as LONG-COVID.
Therefore, the STOP-COVID Registry was established. The purpose of the Registry is to assess the course of COVID-19 infection, early and late cardiovascular complications of COVID-19 in patients with and without hospitalization. In addition, the purpose of the STOP-COVID Registry is to assess the incidence of LONG-COVID with all other complications and to identify predictive factors.
Detailed Description
The following patients are included in the Registry: Patients 18 years and older diagnosed with COVID-19, in accordance with the current guidelines of the Ministry of Health of Poland, after full recovery (resolution of clinical symptoms, minimum 14 days after last symptoms). The Registry includes patients with and without hospitalization .
Approval from the Bioethics Committee of Lodz Regional Medical Chamber to conduct the Registry was obtained.
The Registry was held at the: Saint Family Hospital Medical Center, Lodz, Poland Patient information, course of the disease, post-COVID-19 complaints, comorbidities and current treatment were collected at visit "0" within 4-8 weeks after the end of COVID-19.
Subsequently, patients were ordered the following tests:
- 12-lead ECG
- 24-hour Holter ECG monitoring
- 24-hour Holter blood pressure monitoring
- Echocardiographic of the Heart assessment
- Biochemical tests: Lipid Profile (total cholesterol, LDL fraction, HDL, triglycerides), glucose or glycosylated hemoglobin (HbA1c) level, D-dimers.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients after COVID-19, 18 years and older
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Early and Late COVID-19 cardio-vascular complications
Time Frame: 5 years
Early and Late COVID-19 cardio-vascular complications
Predictors of Long-Covid Cardio-Vascular complications
Time Frame: 5 years
Predictors of Long-Covid Cardio-Vascular complications
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
Time Frame: 5 years
SCORE - algorithm to help to predict the highest risk of Long-Covid complications
Secondary Outcomes
- Detailed patients' characteristics and differences in those with and without Long-Covid complications(5 years)
- Definition and characteristics of the early and Late COVID-19 complications(5 years)
- Comparison of complications and Long-Covid depending on the severity of the course of COVID-19 COVID-19, comorbidities(5 years)
Investigators
Michal Chudzik
Medical Doctor, Cardiologist, Medical Director Ambulatory Clinic
Saint Family Hospital Medical Center