FGF21 Can Help Predicting Arterial Stiffness Measured by Cardio-ankle Vascular Index in Renal Transplant Patients (CAVIFGF21)

July 18, 2016 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event after renal transplantation. And remain a major cause of mortality. The major risk marker is arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall stiffness and can estimated the risk of atherosclerosis.

Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to study the association between CAVI and FGF-21 and their relations to various parameters that can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other traditional basic factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 90 participants who underwent renal transplant were included in the study. The following measures were done and laboratory data were collected. CAVI, Ecchocariogram, Homocysteine, Hs-CRP, Carotid IMT, FGF-21, Medication after renal transplantation, incidence of cardiovascular disease correlation between categorical data was done by using Pearson's correlation test and multiple regression analysis.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10170
        • Bangkok metropolitan administraiton of vajira hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

renal transplant pateints for more than 1 month

Description

Inclusion Criteria:

  • renal transplant patients patients for more than 1 month

Exclusion Criteria:

  • who had contraindication for CAVI
  • current smoker
  • eGFR <15 ml/min/173
  • cardiac arrthymia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAVI and FGF-21
renal transplant patients for more than 1 month measured FGF-21 and CAVI
Other: CAVI and FGF-21
FGf-21 and CAVI was measured in renal transplant patients group and study correlation with arterial stiffness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between CAVI and FGF-21 with arterial stiffness in renal transplant patients
Time Frame: 1 month
cross sectional study
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between Hs-CRP,Homocystein with CAVI
Time Frame: 1 month
cross sectional study
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Investigators

  • Study Director: Thananda Trakarnvanich, M.D., Bangkok metropolitan administration medical college of vajira hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 5, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 085/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data about CAVI and FGF 21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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