Diagnostics of Coronavirus Disease 2019 Cardiovascular Complications

Summary

Aim of this prospective, observational, multi-centered, randomized study is to detect cardiovascular complications in patients after coronavirus infection.

The study will include 100 patients who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion more than 25%, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.

The study consists of 4 periods:

1. Screening for up to 6 months.
2. Inclusion in the study, undergoing of identical laboratory and instrumental testing.
3. Re-examination of patients. After 6 months from the initial examination (9 months after discharge from the infectious diseases department), patients will be re-examined.

4 Determination of end points, statistical data processing.

Estimated result of the study is to confirm or refute the hypothesis:

1. As a result of the analysis of ECG and pulse wave data and comparison with echocardiography data, identify cardiovascular complications of COVID-19 infection.
2. To determine the diagnostic significance of pulse wave parameters for assessing cardiovascular complications in patients with a history of COVID-19 infection (sensitivity, specificity, positive and negative predictive value).
3. Identify correlations between pulse wave parameters and biochemical markers of endothelial dysfunction (endothelin-1).
4. As a result of the analysis of exhaled air by the proton mass spectrometry, to identify markers of cardiovascular complications in patients after COVID-19 infection.
5. As a result of a cardiorespiratory stress test, determine the respiratory and cardiovascular causes of dyspnea, exercise tolerance of patients after infection with COVID-19.

Conditions

• COVID-19
• Endothelial Function
• Diastolic Dysfunction
• Oxygen Consumption
• Quality of Life
• Exercise Tolerance

Interventions

DIAGNOSTIC_TEST

Portable cardiac monitor "CardioQvark"

Record an electrocardiogram (ECG) in one lead with an assessment of the pulse wave using a portable cardiac monitor "CardioQvark" (Russia, LLC "L Card" , RU No. RZN 2019/8124 dated February 15, 2019) once. Devices automatically transfer data to the A\&D Connect app paired with it (link). When transferring data, they are completely protected. The data obtained using the application must be sent to the specialists of the research group in a depersonalized form.

DIAGNOSTIC_TEST

Cardiorespiratory stress test

Cardiorespiratory stress testing with gas analysis using the Quark CPET diagnostic system (COSMED, Italy). The study protocol will consist of 4 phases: rest, warm-up, exercise and recovery. During the load phase, a ramp protocol will be used with a stepped load from 10 to 25 W/min. The increase in power will be calculated individually before the start of the study so that the test lasts 8-12 minutes until complete muscle failure.

DIAGNOSTIC_TEST

Analysis of exhaled air using the Compact PTR-MS proton mass spectrometer

The analysis of exhaled air will be performed using the Compact PTR-MS proton mass spectrometer manufactured by Ionicon (Austria)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University

  lead OTHER

Principal Investigators

• Philippe Yu Kopylov, Professor · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-02

Primary Completion

2024-12-31

Completion

2025-11-30

Countries

• Russia

Study Locations