CKDCARDIO SCARSNCT05125913
Long Term Cardio-Vascular Risk Assessment in CKD and Kidney Transplanted Patients Following SARS-COV-2
An observational study of CKD and Dialysis, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The occurrence of novel coronavirus disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has offered an unmatched global challenge for the healthcare research community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Dialysis, Kidney Transplant
- What is being tested?
- FMD, Arterial stiffness and Assessment of IMT
- How many people
- 250 participants
- Where
- 1 siteRomania
- Study dates
- 4 Jan 2021to 31 Mar 2024
- 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: This prospective case-control study will include CKD stage 3 to 5 patients, dialysis patients and KTx patients.
Who may be able to join
- Age>18 years;
- Patients with CKD stage 3-5, patients on dialysis or KTx patients with confirmed COVID-19, at minimum 2 weeks after the confirmed test;
- Age, sex and kidney disease (CKD stage 3-5, dialysis or KTx) matched patients without confirmed SARS-CoV-2 infection.
Who cannot join
- Prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion;
- Active malignancies.
- Pregnancy;
- Active systemic infections (due to difficulties in the interpretation of nonspecific inflammation biomarkers in this type of patients);
- Congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Dr CI Parhon Clinical Hospital of Iasi
Iași
Adrian C Covic, Professor, accovic@gmail.com
Mugurel Apetrii, Lecturer, mugurelu_1980@yahoo.com
About this study
Official title: Long Term Cardio-Vascular Risk Assessment in CKD and Kidney Transplanted Patients Following SARS-COV-2 Disease: CARDIO SCARS IN CKD Protocol for a Multi-center Observational Match Controlled Trial
The occurrence of novel coronavirus disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has offered an unmatched global challenge for the healthcare research community. SARS-CoV-2 infection is produced by binding to angiotensin-converting enzyme (ACE2), which among other sites is highly expressed in the endothelial cells of the blood vessels, pericytes and the heart, as well as in renal podocytes and proximal tubular epithelial cells. Autopsy studies detected the presence of SARS-CoV-2 in both myocardium and renal tissue, suggesting that COVID-19 profoundly influences the cardiovascular (CV) system and the kidneys and this may lead to long-termed cardio-pulmonary-renal consequences. Data emerging from the general population suggests that COVID-19 is essentially an endothelial disease, with possible deleterious long-term effects that are currently incompletely understood. Therefore, the investigators aim to assess the CV risk in a chronic kidney disease (CKD) including dialysis patients and kidney transplanted (KTx) population, following SARS-CoV-2 infection, by determining the long-term impact of this disease on CV and renal outcomes in the aforementioned population as compared to a control group of matched patients.
Read the detailed description
The coronavirus disease caused by the SARS-CoV-2 first emerged in early December 2019 and was declared a pandemic on March 2020. SARS-CoV-2 infection is produced by binding to ACE2, which among other sites is highly expressed in the endothelial cells of the blood vessels, pericytes and the heart, as well as in renal podocytes and proximal tubular epithelial cells. Of note, ACE2 RNA expression in kidney is nearly 100-fold higher than that in lungs. COVID-19 and cardiovascular disease (CVD) seem to be interconnected; on the one hand, prior CVD as well as CV risk factors are associated with an increased incidence of the disease (with fatal outcomes) and on the other hand COVID-19 can exacerbate associated CVD and determine de novo cardiac complications (acute myocardial injury, stress cardiomyopathy, myocarditis, pericarditis, arrhythmias, heart failure and cardiogenic shock). At the same time, COVID-19 disease can lead to acute kidney injury directly, or due to sepsis, multi-organ failure and shock. The preexistence of both CVD and CKD is associated with a higher risk of severe disease and worse prognosis. CKD patients are already at high risk for CV complications with CVD the leading cause of morbidity and mortality in CKD.
The reported incidence of thrombotic complications in patients with COVID-19 varies between studies, ranging from 25% to 42.6%. It is still under debate if these hemostatic changes are a particular effect of SARS-CoV-2, the inflammatory response, or if they appear secondary to either endothelial dysfunction (ED) or sepsis. Prolonged hypoxemia, cytokine storm and local pulmonary thrombotic phenomena, as well as the associated liver dysfunction secondary to the viral binding to a hepatic receptor are some of the COVID-19's peculiarities that can lead to a higher thrombotic burden. Infection of endothelial cells or perycites is of particular importance because this could lead to severe microvascular and macrovascular dysfunction. ED refers to a systemic condition in which the endothelium loses its physiological properties, including the tendency to promote vasodilation, fibrinolysis, and anti-aggregation. Morphologic findings from deceased patients confirm the presence of viral elements within endothelial cells and an accumulation of inflammatory cells, with evidence of endothelial and inflammatory cell death. Endothelitis in several organs as a direct consequence of viral involvement and of the host inflammatory response may explain the impaired microcirculatory function in different vascular beds and clinical sequel in patients with COVID-19.
The COVID-19 pandemic is forcing healthcare systems and societies to scrutinize how care is delivered and valuable lessons are being learned. Furthermore, as mentioned above, the assessment of CV risk is crucially important for these patients. In this regard, a bedside assembly of reliable and thorough investigations that will provide lasting insights past the time of this pandemic, can become a very valuable tool.
The overall scope of this study is to assess the CV risk in a CKD (stage 3 to 5D) and kidney transplanted population, following COVID-19 infection, with focus on the ED as compared to a control group of matched patients. By using clinical evaluation, flow-mediated dilatation (FMD), pulse wave velocity (PWV), intima media thickness (IMT), echocardiographic parameters, Lung ultrasonography (LUS), bioimpedance spectroscopy (BIS) derived fluid status parameters (over hydration, total body water, extracellular water and intracellular water) and a series of novel biomarkers, the investigators intent to determine the long-term impact of this disease on CV and renal outcomes in the aforementioned population.
- Conditions
- CKD, Dialysis, Kidney Transplant, COVID-19, Cardiovascular Disease, Endothelial Dysfunction
- Being tested
- FMD, Arterial stiffness, Assessment of IMT, Echocardiography, LUS
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMDDiagnostic test
Measurements will be made by using ultrasound system with a 12-Mhz probe. All vasoactive medications will be withheld for 24 h before the procedure. The participants will remain at rest in the supine position for at least 15 minutes before the examination. Each subject's right arm will be comfortably immobilized in the extended position to allow consistent recording of the brachial artery 2-4 cm above the antecubital fossa. If an arteriovenous fistula is present, the contralateral arm will be used for assessment. Three adjacent measurements of end-diastolic brachial artery diameter will be made from single 2D frames. The maximum FMD diameters will be calculated as the average of the three consecutive maximum diameter measurements after hyperemia and nitroglycerin, respectively.
Arterial stiffnessDiagnostic test
Arterial stiffness assessment will be performed by applanation tonometry with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference-acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.
Assessment of IMTDiagnostic test
A high-resolution B-mode ultrasound of the common carotid arteries with scanning of the longitudinal axis until the bifurcation and of the transversal axis will be performed using ultrasonic pulse with a middle frequency of 12 MHz. For each carotid artery, two longitudinal measurements will be obtained by rotating the vessels at 180o increments along their axis. IMT will be measured at 1 cm proximal to the bifurcation on each side.
EchocardiographyDiagnostic test
Echocardiography will be performed on each patient at baseline; the measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
LUSDiagnostic test
Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).
BIS analysisDiagnostic test
This analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device using specific electrodes. Based on a fluid model using 50 discrete frequencies (5-1000kHz), the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. Absolute fluid overload (AFO) is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio.
Biomarkers determinationOther
Biomarkers by ELISA: IL-1, IL-6, VCAM1, Endoglin, NO and ADMA
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Patients with CKD stage 3-5, on dialysis or kidney transplanted patients with confirmed SARS-CoV-2 infection by reverse transcriptase polymerase chain reaction (RT-PCR), at minimum 2 weeks after the confirmed test. Receives: Diagnostic Test: FMD; Diagnostic Test: Arterial stiffness; Diagnostic Test: Assessment of IMT; Diagnostic Test: Echocardiography; Diagnostic Test: LUS; Diagnostic Test: BIS analysis; Other: Biomarkers determination | |
| non-COVID-19 group | CKD stage 3-5, dialysis or kidney transplantation matched patients without confirmed SARS-CoV-2 infection Receives: Diagnostic Test: FMD; Diagnostic Test: Arterial stiffness; Diagnostic Test: Assessment of IMT; Diagnostic Test: Echocardiography; Diagnostic Test: LUS; Diagnostic Test: BIS analysis; Other: Biomarkers determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
One of the primary outcome of this study will be all-cause mortality rate.
Measured: 24 months post-COVID-19
MACE
Another primary outcome will be a composite CV outcome (time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death).
Measured: 24 months post-COVID-19
Endothelial dysfunction
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
Measured: 6 months post-COVID-19
Endothelial dysfunction
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
Measured: 12 months post-COVID-19
Endothelial dysfunction
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
Measured: 24 months post-COVID-19
Secondary outcomes (3)
Renal outcome
Secondary outcomes are defined as a composite of renal outcome: doubling of creatinine or a 40% decline in eGFR or dialysis initiation in CKD or KTx patients.
Measured: 6 months post-COVID-19
Renal outcome
Secondary outcomes are defined as a composite of renal outcome: doubling of creatinine or a 40% decline in eGFR or dialysis initiation in CKD or KTx patients.
Measured: 12 months post-COVID-19
Renal outcome
Secondary outcomes are defined as a composite of renal outcome: doubling of creatinine or a 40% decline in eGFR or dialysis initiation in CKD or KTx patients.
Measured: 24 months post-COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start4 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
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 CKDStudies 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Adrian C Covic, Professor, Study director, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125913
- Sponsor's protocol ID
- Cardio Scars
- Acronym
- CARDIO SCARS
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tapoi L, Apetrii M, Dodi G, Nistor I, Voroneanu L, Siriteanu L, Onofriescu M, Kanbay M, Covic A. Long-term cardio-vascular risk assessment in chronic kidney disease and kidney transplanted patients following SARS-COV-2 disease: protocol for multi-center observational match controlled trial. BMC Nephrol. 2022 May 6;23(1):176. doi: 10.1186/s12882-022-02809-4.
PubMed 35524223
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Cardio-Vascular Risk Assessment in CKD and Kidney Transplanted Patients Following SARS-COV-2 Disease: CARDIO SCARS IN CKD Protocol for a Multi-center Observational Match Controlled Trial
- ClinicalTrials.gov ID
- NCT05125913
- Acronym / sponsor ID
- CARDIO SCARS / Cardio Scars
- Conditions
- CKD, Dialysis, Kidney Transplant, COVID-19, Cardiovascular Disease, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Nov 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.
The occurrence of novel coronavirus disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has offered an unmatched global challenge for the healthcare research community. SARS-CoV-2 infection is produced by binding to angiotensin-converting enzyme (ACE2), which among other sites is highly expressed in the endothelial cells of the blood vessels, pericytes and the heart, as well as in renal podocytes and proximal tubular epithelial cells. Autopsy studies detected the presence of SARS-CoV-2 in both myocardium and renal tissue, suggesting that COVID-19 profoundly influences the cardiovascular (CV) system and the kidneys and this may lead to long-termed cardio-pulmonary-renal consequences. Data emerging from the general population suggests that COVID-19 is essentially an endothelial disease, with possible deleterious long-term effects that are currently incompletely understood. Therefore, the investigators aim to assess the CV risk in a chronic kidney disease (CKD) including dialysis patients and kidney transplanted (KTx) population, following SARS-CoV-2 infection, by determining the long-term impact of this disease on CV and renal outcomes in the aforementioned population as compared to a control group of matched patients.
Detailed description
The coronavirus disease caused by the SARS-CoV-2 first emerged in early December 2019 and was declared a pandemic on March 2020. SARS-CoV-2 infection is produced by binding to ACE2, which among other sites is highly expressed in the endothelial cells of the blood vessels, pericytes and the heart, as well as in renal podocytes and proximal tubular epithelial cells. Of note, ACE2 RNA expression in kidney is nearly 100-fold higher than that in lungs. COVID-19 and cardiovascular disease (CVD) seem to be interconnected; on the one hand, prior CVD as well as CV risk factors are associated with an increased incidence of the disease (with fatal outcomes) and on the other hand COVID-19 can exacerbate associated CVD and determine de novo cardiac complications (acute myocardial injury, stress cardiomyopathy, myocarditis, pericarditis, arrhythmias, heart failure and cardiogenic shock). At the same time, COVID-19 disease can lead to acute kidney injury directly, or due to sepsis, multi-organ failure and shock. The preexistence of both CVD and CKD is associated with a higher risk of severe disease and worse prognosis. CKD patients are already at high risk for CV complications with CVD the leading cause of morbidity and mortality in CKD.
The reported incidence of thrombotic complications in patients with COVID-19 varies between studies, ranging from 25% to 42.6%. It is still under debate if these hemostatic changes are a particular effect of SARS-CoV-2, the inflammatory response, or if they appear secondary to either endothelial dysfunction (ED) or sepsis. Prolonged hypoxemia, cytokine storm and local pulmonary thrombotic phenomena, as well as the associated liver dysfunction secondary to the viral binding to a hepatic receptor are some of the COVID-19's peculiarities that can lead to a higher thrombotic burden. Infection of endothelial cells or perycites is of particular importance because this could lead to severe microvascular and macrovascular dysfunction. ED refers to a systemic condition in which the endothelium loses its physiological properties, including the tendency to promote vasodilation, fibrinolysis, and anti-aggregation. Morphologic findings from deceased patients confirm the presence of viral elements within endothelial cells and an accumulation of inflammatory cells, with evidence of endothelial and inflammatory cell death. Endothelitis in several organs as a direct consequence of viral involvement and of the host inflammatory response may explain the impaired microcirculatory function in different vascular beds and clinical sequel in patients with COVID-19.
The COVID-19 pandemic is forcing healthcare systems and societies to scrutinize how care is delivered and valuable lessons are being learned. Furthermore, as mentioned above, the assessment of CV risk is crucially important for these patients. In this regard, a bedside assembly of reliable and thorough investigations that will provide lasting insights past the time of this pandemic, can become a very valuable tool.
The overall scope of this study is to assess the CV risk in a CKD (stage 3 to 5D) and kidney transplanted population, following COVID-19 infection, with focus on the ED as compared to a control group of matched patients. By using clinical evaluation, flow-mediated dilatation (FMD), pulse wave velocity (PWV), intima media thickness (IMT), echocardiographic parameters, Lung ultrasonography (LUS), bioimpedance spectroscopy (BIS) derived fluid status parameters (over hydration, total body water, extracellular water and intracellular water) and a series of novel biomarkers, the investigators intent to determine the long-term impact of this disease on CV and renal outcomes in the aforementioned population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | Diagnostic Test: FMD, Diagnostic Test: Arterial stiffness, Diagnostic Test: Assessment of IMT, Diagnostic Test: Echocardiography, Diagnostic Test: LUS, Diagnostic Test: BIS analysis, Other: Biomarkers determinationPatients with CKD stage 3-5, on dialysis or kidney transplanted patients with confirmed SARS-CoV-2 infection by reverse transcriptase polymerase chain reaction (RT-PCR), at minimum 2 weeks after the confirmed test. |
| non-COVID-19 group | – | Diagnostic Test: FMD, Diagnostic Test: Arterial stiffness, Diagnostic Test: Assessment of IMT, Diagnostic Test: Echocardiography, Diagnostic Test: LUS, Diagnostic Test: BIS analysis, Other: Biomarkers determinationCKD stage 3-5, dialysis or kidney transplantation matched patients without confirmed SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective case-control study will include CKD stage 3 to 5 patients, dialysis patients and KTx patients.
Key inclusion criteria (3 listed)
- Age>18 years;
- Patients with CKD stage 3-5, patients on dialysis or KTx patients with confirmed COVID-19, at minimum 2 weeks after the confirmed test;
- Age, sex and kidney disease (CKD stage 3-5, dialysis or KTx) matched patients without confirmed SARS-CoV-2 infection.
Key exclusion criteria (5 listed)
- Prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion;
- Active malignancies.
- Pregnancy;
- Active systemic infections (due to difficulties in the interpretation of nonspecific inflammation biomarkers in this type of patients);
- Congenital heart disease.
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 |
|---|---|---|
| FMDMeasurements will be made by using ultrasound system with a 12-Mhz probe. All vasoactive medications will be withheld for 24 h before the procedure. The participants will remain at rest in the supine position for at least 15 minutes before the examination. Each subject's right arm will be comfortably immobilized in the extended position to allow consistent recording of the brachial artery 2-4 cm above the antecubital fossa. If an arteriovenous fistula is present, the contralateral arm will be used for assessment. Three adjacent measurements of end-diastolic brachial artery diameter will be made from single 2D frames. The maximum FMD diameters will be calculated as the average of the three consecutive maximum diameter measurements after hyperemia and nitroglycerin, respectively. | Diagnostic test | COVID-19 group, non-COVID-19 group |
| Arterial stiffnessArterial stiffness assessment will be performed by applanation tonometry with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference-acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV. | Diagnostic test | COVID-19 group, non-COVID-19 group |
| Assessment of IMTA high-resolution B-mode ultrasound of the common carotid arteries with scanning of the longitudinal axis until the bifurcation and of the transversal axis will be performed using ultrasonic pulse with a middle frequency of 12 MHz. For each carotid artery, two longitudinal measurements will be obtained by rotating the vessels at 180o increments along their axis. IMT will be measured at 1 cm proximal to the bifurcation on each side. | Diagnostic test | COVID-19 group, non-COVID-19 group |
| EchocardiographyEchocardiography will be performed on each patient at baseline; the measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium). | Diagnostic test | COVID-19 group, non-COVID-19 group |
| LUSExaminations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line). | Diagnostic test | COVID-19 group, non-COVID-19 group |
| BIS analysisThis analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device using specific electrodes. Based on a fluid model using 50 discrete frequencies (5-1000kHz), the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. Absolute fluid overload (AFO) is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio. | Diagnostic test | COVID-19 group, non-COVID-19 group |
| Biomarkers determinationBiomarkers by ELISA: IL-1, IL-6, VCAM1, Endoglin, NO and ADMA | Other | COVID-19 group, non-COVID-19 group |
Primary outcome
Mortality rate
Time frame: 24 months post-COVID-19
One of the primary outcome of this study will be all-cause mortality rate.
MACE
Time frame: 24 months post-COVID-19
Another primary outcome will be a composite CV outcome (time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death).
Endothelial dysfunction
Time frame: 6 months post-COVID-19
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
Endothelial dysfunction
Time frame: 12 months post-COVID-19
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
Endothelial dysfunction
Time frame: 24 months post-COVID-19
The investigators will determine long-term impact of the COVID-19 on markers of CV risk and ED in all included patients.
3 secondary outcomes
Renal outcome
Time frame: 6 months post-COVID-19
Renal outcome
Time frame: 12 months post-COVID-19
Renal outcome
Time frame: 24 months post-COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 35524223Tapoi L, Apetrii M, Dodi G, Nistor I, Voroneanu L, Siriteanu L, Onofriescu M, Kanbay M, Covic A. Long-term cardio-vascular risk assessment in chronic kidney disease and kidney transplanted patients following SARS-COV-2 disease: protocol for multi-center observational match controlled trial. BMC Nephrol. 2022 May 6;23(1):176. doi: 10.1186/s12882-022-02809-4.
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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.
Adrian C Covic, Professor study director
Grigore T. Popa University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Dialysis, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mugurel Apetrii, Lecturer (+40232211818, mugurelu_1980@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 24 months post-COVID-19). The study lists 5 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 NCT05125913, 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 21 Jan 2022.