Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.

Study 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.

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

Conditions
-----------------
Cardiovascular Diseases, Carotid Intimal Media Thickness, Left Ventricular Hypertrophy, Mean Platelet Volume, End Stage Renal Disease, Hemodialysis Complication, Peritoneal Dialysis Complication, Children

Intervention / Treatment
-----------------
* Diagnostic Test: Imaging
* Other: Blood sampling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Children with end stage renal disease | Diagnostic Test: Imaging<br>* Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness<br>Other: Blood sampling<br>* Blood sampling will performed on all participants for measuring hematological parameters including MPV.<br>|
| Controls<br>Healthy sex- and age adjusted children | Diagnostic Test: Imaging<br>* Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness<br>Other: Blood sampling<br>* Blood sampling will performed on all participants for measuring hematological parameters including MPV.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPV in patients and controls | Comparing the mean of MPV in patients and controls. | 1 year after study beginning | 
| Echocardiographic indices in patients and controls | Comparing the means of echocardiographic indices in patients and controls | 1.5 years after study beginning | 
| Carotid intima media thickness in patients and controls | Comparing the mean of carotid intima media thickness in patients and controls | 2 years after study beginning | 
| Correlation between MPV and ejection fraction | Determining correlation between the value of MPV with ejection fraction in patients | 1.5 years after study beginning | 
| Correlation between MPV and left ventricular mass index | Determining correlation between the value of MPV with left ventricular mass index in patients | 1.5 years after study beginning | 
| Correlation between MPV and strain rate | Determining correlation between the value of MPV with strain rate in patients | 1.5 years after study beginning | 
| Correlation between MPV and global longitudinal strain | Determining correlation between the value of MPV with global longitudinal strain in patients | 1.5 years after study beginning | 
| Correlation between MPV and carotid intima media thickness | Determining correlation between the value of MPV with carotid intima media thickness in patients | 2 years after study beginning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPV and thrombotic events | Comparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident | 2 years after study beginning |