Carotid Intima-media Thickness in Dialysis Patients and T... | NCT07558239

Studies
Carotid Intima-media Thickness in Dialysis Patients and Traditional Risk Factors

NCT07558239

Sponsor

Minia University

Status

Not yet recruiting

Last Update Posted

Apr 30, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Dialysis Patients
Hypertension
Atherosclerosis

Interventions

Ultrasound measurements of carotid intima- media thickness

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2026Estimated

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Apr 23, 2026

First Submission Date that Met QC Criteria

Apr 23, 2026

First Posted Date

Apr 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiovascular disease (CVD) is the leading cause of mortality in hemodialysis (HD) patients.
Carotid intima-media thickness (CIMT) is a validated surrogate marker for atherosclerosis.
Both traditional cardiovascular risk factors (hypertension, diabetes, dyslipidemia) and dialysis-specific factors (mineral metabolism disorders, dialysis duration) contribute to vascular damage.

Detailed Description

Cardiovascular disease (CVD) is the leading cause of mortality in hemodialysis (HD) patients.
Carotid intima-media thickness (CIMT) is a validated surrogate marker for atherosclerosis.
Both traditional cardiovascular risk factors (hypertension, diabetes, dyslipidemia) and dialysis-specific factors (mineral metabolism disorders, dialysis duration) contribute to vascular damage.
Gap in knowledge: Few studies have comprehensively assessed the combined impact of these factors on CIMT in HD patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound measurements of carotid intima- media thickness	Other	Ultrasound measurements of carotid intima- media thickness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• To determine the association between carotid intima - media thickness and: o Hypertension duration o HbA1c o LDL/HDL ratio o Dialysis duration o Parathyroid hormone (PTH) levels		6 month

Secondary Outcomes

Measure	Description	Time Frame
• To compare CIMT between: o Diabetics vs. non-diabetics o Short (<5 yrs) vs. long (≥5 yrs) dialysis duration o Patients with vs. without hyperparathyroidism (PTH >300 pg/m		6month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Age 18 or older. 2. Patients with sepsis without AKI at the time of admission.

Exclusion Criteria:

o Active malignancy
- Acute infections
- Recent cardiovascular events (<3 months)
- Poor echocardiographic window for CIMT measurement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Renal dialysis patients

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	https://doi.org/10.1016/j.atherosclerosis.2019.06.560

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Term
D006973	Hypertension
D050197	Atherosclerosis