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Clinical Trials/NCT03759002
NCT03759002
Completed
Not Applicable

Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.

Isfahan University of Medical Sciences0 sites102 target enrollmentFebruary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Isfahan University of Medical Sciences
Enrollment
102
Primary Endpoint
MPV in patients and controls
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.

Registry
clinicaltrials.gov
Start Date
February 1, 2016
End Date
June 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amin Abedini

Medical researcher

Isfahan University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group.
  • Age and gender matched healthy children who have been referred for routine medical examination.

Exclusion Criteria

  • Patients with uncontrolled hypertension (until being stabled)
  • Patients on any kind of antithrombotic agents or NSAIDs
  • Severe obesity
  • Diabetes patients
  • Patients with a past history of CVD or stroke in the last 6 months
  • Passive smokers who contacted daily with high smokers in their houses
  • Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)
  • Uncontrolled hypothyroid or hyperthyroid patients
  • Patients with recent (in the last 4 weeks) catheter or exit -site infection.

Outcomes

Primary Outcomes

MPV in patients and controls

Time Frame: 1 year after study beginning

Comparing the mean of MPV in patients and controls.

Carotid intima media thickness in patients and controls

Time Frame: 2 years after study beginning

Comparing the mean of carotid intima media thickness in patients and controls

Echocardiographic indices in patients and controls

Time Frame: 1.5 years after study beginning

Comparing the means of echocardiographic indices in patients and controls

Correlation between MPV and ejection fraction

Time Frame: 1.5 years after study beginning

Determining correlation between the value of MPV with ejection fraction in patients

Correlation between MPV and left ventricular mass index

Time Frame: 1.5 years after study beginning

Determining correlation between the value of MPV with left ventricular mass index in patients

Correlation between MPV and strain rate

Time Frame: 1.5 years after study beginning

Determining correlation between the value of MPV with strain rate in patients

Correlation between MPV and global longitudinal strain

Time Frame: 1.5 years after study beginning

Determining correlation between the value of MPV with global longitudinal strain in patients

Correlation between MPV and carotid intima media thickness

Time Frame: 2 years after study beginning

Determining correlation between the value of MPV with carotid intima media thickness in patients

Secondary Outcomes

  • MPV and thrombotic events(2 years after study beginning)

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