Cardiovascular DiseasesNCT03759002
Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.
An observational study of Cardiovascular Diseases and Carotid Intimal Media Thickness, run by Isfahan University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Carotid Intimal Media Thickness, Left Ventricular Hypertrophy
- What is being tested?
- Imaging and Blood sampling
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients group will be selected from children who referred to a tertiary care center of pediatric nephrology diseases. Controls will be chosen from healthy volunteers who will be visited for medical routine examination in the hospital staff.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
About this study
Official title: Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.
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.
- Conditions
- Cardiovascular Diseases, Carotid Intimal Media Thickness, Left Ventricular Hypertrophy, Mean Platelet Volume, End Stage Renal Disease, Hemodialysis Complication
- Being tested
- Imaging, Blood sampling
- Medical subject headings
- Cardiovascular Diseases, Hypertrophy, Left Ventricular, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
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
Blood samplingOther
Blood sampling will performed on all participants for measuring hematological parameters including MPV.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Children with end stage renal disease Receives: Diagnostic Test: Imaging; Other: Blood sampling | |
| Controls | Healthy sex- and age adjusted children Receives: Diagnostic Test: Imaging; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPV in patients and controls
Comparing the mean of MPV in patients and controls.
Measured: 1 year after study beginning
Echocardiographic indices in patients and controls
Comparing the means of echocardiographic indices in patients and controls
Measured: 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
Measured: 2 years after study beginning
Correlation between MPV and ejection fraction
Determining correlation between the value of MPV with ejection fraction in patients
Measured: 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
Measured: 1.5 years after study beginning
Correlation between MPV and strain rate
Determining correlation between the value of MPV with strain rate in patients
Measured: 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
Measured: 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
Measured: 2 years after study beginning
Secondary outcomes (1)
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
Measured: 2 years after study beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Feb 2016
- Primary completion1 Feb 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Abedini, Isfahan University of Medical Sciences
- Investigators
- Alaleh Gheissari, M.D., Principal investigator, Professor of pediatric nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759002
- Sponsor's protocol ID
- 395723
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.
- ClinicalTrials.gov ID
- NCT03759002
- Acronym / sponsor ID
- 395723
- Conditions
- Cardiovascular Diseases, Carotid Intimal Media Thickness, Left Ventricular Hypertrophy, Mean Platelet Volume, End Stage Renal Disease, Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Imaging, Other: Blood samplingChildren with end stage renal disease |
| Controls | – | Diagnostic Test: Imaging, Other: Blood samplingHealthy sex- and age adjusted children |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients group will be selected from children who referred to a tertiary care center of pediatric nephrology diseases. Controls will be chosen from healthy volunteers who will be visited for medical routine examination in the hospital staff.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingImaging 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 | Diagnostic test | Controls, Patients |
| Blood samplingBlood sampling will performed on all participants for measuring hematological parameters including MPV. | Other | Controls, Patients |
Primary outcome
MPV in patients and controls
Time frame: 1 year after study beginning
Comparing the mean of MPV 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
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
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
1 secondary outcome
MPV and thrombotic events
Time frame: 2 years after study beginning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaleh Gheissari, M.D. principal investigator
Professor of pediatric nephrology
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Carotid Intimal Media Thickness, run by Isfahan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPV in patients and controls (time frame: 1 year after study beginning). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.