Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06211244
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-08
Brief Title:
Association of Serum Eotaxin Levels and Markers of Myocardiac Injury in Hemodialysis Patients
Sponsor:
Tungs Taichung Metroharbour Hospital
Organization:
Tungs Taichung Metroharbour Hospital
Study Overview
Official Title:
Association of Serum Eotaxin Levels and Markers of Myocardiac Injury in Hemodialysis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Cardiovascular disease CVD is one of the leading causes of morbidity and mortality among dialysis patients Eotaxin-1also known as Eotaxin and CCL11 an eosinophil-specific chemoattractant that plays a role in a variety of pathologic conditions including allergy coronary heart disease and inflammatory bowel disease CCL11 has been shown to be overexpressed in human atherosclerotic lesions Moreover eotaxin-1 levels are higher in non-uremic coronary artery disease patients than in healthy individuals
Methods
The study will enrolled 400 hemodialysis patients Patients are diagnosed with coronary artery disease based on clinical presentation and confirmed by angiography Serum eotaxin-1 and 8-isoprostane levels are determined by enzyme-linked immunosorbent assay ELISA High-sensitivity cTnI immunoassays and albumin redox state by high-performance liquid chromatography are used for measurements
Aim
In this study we aimed to determine the eotaxin-1 concentrations of patients with coronary artery disease and to investigate the role of eotaxin-1 and markers of myocardial injury
Cardiovascular disease CVD is one of the leading causes of morbidity and mortality among dialysis patients Eotaxin-1also known as Eotaxin and CCL11 an eosinophil-specific chemoattractant that plays a role in a variety of pathologic conditions including allergy coronary heart disease and inflammatory bowel disease CCL11 has been shown to be overexpressed in human atherosclerotic lesions Moreover eotaxin-1 levels are higher in non-uremic coronary artery disease patients than in healthy individuals
Methods
The study will enrolled 400 hemodialysis patients Patients are diagnosed with coronary artery disease based on clinical presentation and confirmed by angiography Serum eotaxin-1 and 8-isoprostane levels are determined by enzyme-linked immunosorbent assay ELISA High-sensitivity cTnI immunoassays and albumin redox state by high-performance liquid chromatography are used for measurements
Aim
In this study we aimed to determine the eotaxin-1 concentrations of patients with coronary artery disease and to investigate the role of eotaxin-1 and markers of myocardial injury
Detailed Description:
Study Design and Patient Population This cross-sectional trial and will be carried out in accordance with the Declaration of Helsinki and applicable regulations The protocol will be sent to the institutional ethics committee and patients written informed consent will be obtained To be included in the study patients will be at least 20-years-old and on outpatient HD for at least 3 months All the patients were dialyzed three times a week with a high-flux membrane and bicarbonate dialysate solutions Patients will excluded if they had an acute infection or malignancy A total of 400 long-term HD patients are randomly invited and enrolled in the study The medical records will thoroughly reviewed for each subject by a collaborating physician in the study Information such as underlying kidney disease cardiovascular disease history and other comorbid illnesses are abstracted A pre-existing history of CVD was defined as a history of CAD including a history of myocardial infarction coronary artery angioplastystentingbypass surgery carotid endarterectomystenting cerebrovascular disease CVD eg stroke non-traumatic lower extremity amputation and lower limb artery bypass surgeryangioplastystenting
Measurements Predialysis blood samples are obtained on a mid-week dayWithin 30 min after sampling the remaining blood arecentrifuged at 3000 g for 10 min immediately aliquoted and frozen at-80 C until further analysis The total serum cholesterol is measured through the reaction of cholesterol esterasecholesterol oxidaseperoxidase using Hitachi 747 Hitachi Bohemia NY USA HDL cholesterol is quantified after precipitation with polyethylene glycol at room temperature Serum glucose concentrations are measured by the glucose oxidase method Low-density lipoprotein cholesterol was calculated using the Friedewald formula Total serum triglycerides were measured through the reaction of glycerol phosphateoxidase and peroxidase The serum levels of high-sensitivity C-reactive protein hsCRP are measured using a Behring Nephelometer II Dade Behring Tokyo Japan Serum levels of IL-6 and MCP-1 are measured by a commercially available enzyme-linked immunosorbent assay Quantikine HS Immunoassaykit RD System Minneapolis MN USA Serum 8-isoprostane concentrations were measured using the ELISA assay Cayman Chemical Ann Arbor Michigan USA with a detection limit of 3 pgmL according to the manufacturers instruction
Serum eotaxin levels will be determined using a commercial ELISA kit RD systems Minneapolis MN USAaccording to the manufacturers protocol In brief mouse antihuman antibody against eotaxin is used to capture eotaxin from plasma Captured eotaxin is detected with biotynilated goat antihuman eotaxin antibody After washing plates are incubated with streptavidin-HRP developed with appropriate substrate and OD450 is determined using an ELISA plate reader Measurements are done in duplicate in an assay able to detect 10 pg of eotaxinml The intraand inter-assay coefficients of variation values are 4 and 6 respectively
The Siemens Atellica IM High Sensitivity Troponin I assay Siemens Healthineers is a three-site sandwich immunoassay with a limit of detection of 16 ngL and limit of quantification of 25 ngL The upper reference limit 99th centile was determined in 2007 samples from healthy individuals as 34 ngL in women and 53 ngL in men with a single threshold of 45 ngL In the reference range population 75 of patients had values greater than the limit of detection All measurements were undertaken at a central laboratory who were blinded to all clinical information with results provided to the research team and linked to the trial database for analysis
The redox state of serum albumin was determined by fractionating it into human mercaptalbumin HMA human nonmercaptalbumin-1 HNA-1 and human non-mercaptalbumin-2 HNA-2 with high-performance liquid chromatography HPLC
Measurements Predialysis blood samples are obtained on a mid-week dayWithin 30 min after sampling the remaining blood arecentrifuged at 3000 g for 10 min immediately aliquoted and frozen at-80 C until further analysis The total serum cholesterol is measured through the reaction of cholesterol esterasecholesterol oxidaseperoxidase using Hitachi 747 Hitachi Bohemia NY USA HDL cholesterol is quantified after precipitation with polyethylene glycol at room temperature Serum glucose concentrations are measured by the glucose oxidase method Low-density lipoprotein cholesterol was calculated using the Friedewald formula Total serum triglycerides were measured through the reaction of glycerol phosphateoxidase and peroxidase The serum levels of high-sensitivity C-reactive protein hsCRP are measured using a Behring Nephelometer II Dade Behring Tokyo Japan Serum levels of IL-6 and MCP-1 are measured by a commercially available enzyme-linked immunosorbent assay Quantikine HS Immunoassaykit RD System Minneapolis MN USA Serum 8-isoprostane concentrations were measured using the ELISA assay Cayman Chemical Ann Arbor Michigan USA with a detection limit of 3 pgmL according to the manufacturers instruction
Serum eotaxin levels will be determined using a commercial ELISA kit RD systems Minneapolis MN USAaccording to the manufacturers protocol In brief mouse antihuman antibody against eotaxin is used to capture eotaxin from plasma Captured eotaxin is detected with biotynilated goat antihuman eotaxin antibody After washing plates are incubated with streptavidin-HRP developed with appropriate substrate and OD450 is determined using an ELISA plate reader Measurements are done in duplicate in an assay able to detect 10 pg of eotaxinml The intraand inter-assay coefficients of variation values are 4 and 6 respectively
The Siemens Atellica IM High Sensitivity Troponin I assay Siemens Healthineers is a three-site sandwich immunoassay with a limit of detection of 16 ngL and limit of quantification of 25 ngL The upper reference limit 99th centile was determined in 2007 samples from healthy individuals as 34 ngL in women and 53 ngL in men with a single threshold of 45 ngL In the reference range population 75 of patients had values greater than the limit of detection All measurements were undertaken at a central laboratory who were blinded to all clinical information with results provided to the research team and linked to the trial database for analysis
The redox state of serum albumin was determined by fractionating it into human mercaptalbumin HMA human nonmercaptalbumin-1 HNA-1 and human non-mercaptalbumin-2 HNA-2 with high-performance liquid chromatography HPLC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None