Thrombospondin-4 Levels and Peripheral Arterial Disease in Hemodialysis Patients

NCT04735562 | Completed DMC

• 1 other identifier: 109056
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Thrombospondin-4; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Analysis of biomarkers of thrombospondin-4 levels

  Plasma level of thrombospondin-4 is a biomarkers for the risk of developing and presence of PAD

  1 years

Secondary Outcomes (5)

• Ankle Brachial Index Measurements

  1 years

• Analysis of biomarkers of hs-cTnT

  1 years

• Analysis of biomarkers of N-terminal probrain natriuretic peptide

  1 years

• Analysis of biomarkers of a-Klotho

  1 years

• Analysis of biomarkers of FABP-4

  1 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients have to be at least 20-years-old and hemodialysis (HD) for at least 3 months.

You may qualify if:

• A cohort of aged 20 or over, who have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

TW (1)