Long Term Cardio-Vascular Risk Assessment in CKD and Kidney Transplanted Patients Following SARS-COV-2
CARDIO SCARS
1 other identifier
observational
250
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2021
CompletedFirst Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedJanuary 21, 2022
January 1, 2022
3 years
November 10, 2021
January 5, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Mortality rate
One of the primary outcome of this study will be all-cause mortality rate.
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).
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.
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.
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.
24 months post-COVID-19
Secondary Outcomes (3)
Renal outcome
6 months post-COVID-19
Renal outcome
12 months post-COVID-19
Renal outcome
24 months post-COVID-19
Study Arms (2)
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.
non-COVID-19 group
CKD stage 3-5, dialysis or kidney transplantation matched patients without confirmed SARS-CoV-2 infection
Interventions
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 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.
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.
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).
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).
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 by ELISA: IL-1, IL-6, VCAM1, Endoglin, NO and ADMA
Eligibility Criteria
This prospective case-control study will include CKD stage 3 to 5 patients, dialysis patients and KTx patients.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr CI Parhon Clinical Hospital of Iasi
Iași, Romania
Related Publications (1)
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.
PMID: 35524223DERIVED
Biospecimen
Serum samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adrian C Covic, Professor
Grigore T. Popa University of Medicine and Pharmacy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 18, 2021
Study Start
January 4, 2021
Primary Completion
December 31, 2023
Study Completion
March 31, 2024
Last Updated
January 21, 2022
Record last verified: 2022-01