Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04735562 |
| Other study ID # |
109056 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Tungs' Taichung Metroharbour Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Peripheral arterial disease (PAD) a condition characterized by atherosclerotic occlusive
disease of the lower extremities is commonly observed in patients with chronic kidney disease
(CKD) patients, particularly those on dialysis. The investigators conducted detailed
biomarkers such as thrombospondin and related inflammatory biomarkers for the risk of
developing and presence of PAD. Thrombospondin-4 (TSP-4) is an extracellular matrix protein
of the vessel wall. Despite bench evidence, its significance in the clinical setting of
chronic kidney disease (CKD) is missing
Methods:
This is a cross-sectional, single-center study. A cohort of 450 patients aged 20 or over, who
have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included.
TSP-4 and TSP-1 will be measured in HD patients using a commercially available ELISA. PAD is
diagnosed by the ankle-brachial index (ABI) We will measure related blood biomarkers such as
serum hs-cTnT, N-terminal probrain natriuretic peptide, s-Klotho and FABP-4.
Description:
Study Population and Data Source This is a cross-sectional, single-center study which will be
conducted in the Dialysis Center of Tungs' Taichung MetroHarbor Hospital (TTMHH) in the
coastal region of central Taiwan. A cohort of 450 patients aged 20 or over, who have been on
HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included. The medical
charts of these patients are reviewed for eligibility identification, and should be
compatible with the inclusion/exclusion criteria and enrolled in our analysis.
In this study, the diagnostic criterion for asymptomatic PAD is an ABI value lower than or
equal to 0.9 with no clinical symptoms in the lower limb such as muscle discomfort or
intermittent claudication. PAD is considered symptomatic if patients have an ABI ≤0.9 and
clinical symptoms or if they undergo previous surgical revascularization procedures or limb
amputation. The characteristics of patients will be exclude from our study were (1) baseline
ABI values > 1.3 , (2) symptomatic PAD , (3) decompensated cirrhosis , (4) neoplastic
diseases , (5) incomplete data, (6) receiving hemodialysis < 3 months and active infection.
The baseline data such as demographics, comorbidities, anthropometrics, and relevant
laboratory data, clinical diagnosis of PAD based on measurements of ABI, and medication
history will be collected.
Ankle Brachial Index Measurements The ABI was measured by trained technicians using the
Fukuda Vascular Screening System (VaSera VS-1000™, Fukuda Denshi Co., Ltd., Tokyo, Japan),
which measures blood pressure from bilateral arm and ankle (brachial and posterior tibial
arteries, resp.) simultaneously by an oscillometric method. The systolic pressure of the arm
without dialysis access and the lower value of the ankle systolic pressure were used for the
calculation. ABI was calculated by the ratio of the ankle systolic pressure divided by the
arm systolic pressure. Of the two ABI values, respectively, calculated from the left- and
right-limb measurements, the lowest value is used in this study. All participants were
annually measured in a supine position after resting for at least 15 minutes and before
dialysis.
In this study, ABI less than 0.90 was considered as evidence of PAD . Absence of PAD was
defined as ABI between 0.90 and 1.30 . Individuals with ABI greater than 1.30 were excluded,
because this indicates poorly compressible leg arteries and inability to gauge arterial
perfusion accurately .
Laboratory Mesaurements Blood was drawn with EDTA anticoagulant in the morning after an
overnight fast of at least 12 h before a dialysis session. The samples were separated via
centrifugation (4000 rpm, 10 min) and immediately stored at -80°C for subsequent assays.
Glucose, high-density lipoprotein cholesterol HDL), triglycerides and total cholesterol are
all measured by standard assays using the analyzer. Low-density lipoprotein cholesterol (LDL)
is measured by standard assay. Beta 2 microglobulin, high-sensitivity C-reactive protein
(hsCRP) and are measuredusing standard nephelometry. Serum hs-cTnT was measured using a
sandwich immunoassay method, a novel highly sensitive assay with a lower measurable limit of
3 ng/L. N-terminal probrain natriuretic peptide(NT-proBNP) is measured using a sandwich
immunoassay method, the lower limits of quantification were 5 pg/mL. The serum levels of
a-Klotho were measured using an enzyme linked immunosorbent assay (ELISA) system, and this
assay detects circulating a-Klotho using 2 monoclonal antibodies that specifically recognize
the extracellular domain of Klotho, the lower limits of quantification were 6.15 pg/mL and
the intra-assay and interassay coefficients of variation of <10%. Plasma blood concentrations
of FABP4 were measured by means of (sandwich) ELISA (enzyme-linked immunosorbent assay).
Plasma TSP-1 and TSP-4 levels were assessed via ELISA. Calculated intra-assay and interassay
coefficient of variation for TSP-4 were 9.3% and 7.7%, respectively.
