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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759002
• Other study ID #: 395723
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: November 2018
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 15, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Carotid Intimal Media Thickness
• Children
• End Stage Renal Disease
• Hemodialysis Complication
• Hypertrophy
• Hypertrophy, Left Ventricular
• Kidney Diseases
• Kidney Failure, Chronic
• Left Ventricular Hypertrophy
• Mean Platelet Volume
• Peritoneal Dialysis Complication

Intervention

Diagnostic Test:
• Imaging
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

Other:
• Blood sampling
Blood sampling will performed on all participants for measuring hematological parameters including MPV.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPV in patients and controls	Comparing the mean of MPV in patients and controls.	1 year after study beginning
Primary	Echocardiographic indices in patients and controls	Comparing the means of echocardiographic indices in patients and controls	1.5 years after study beginning
Primary	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
Primary	Correlation between MPV and ejection fraction	Determining correlation between the value of MPV with ejection fraction in patients	1.5 years after study beginning
Primary	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
Primary	Correlation between MPV and strain rate	Determining correlation between the value of MPV with strain rate in patients	1.5 years after study beginning
Primary	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
Primary	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	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