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AzTrials

Vascular StiffnessCAVIFGF21NCT02704468

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

An observational study of Vascular Stiffness, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vascular Stiffness
What is being tested?
CAVI and FGF-21
How many people
100 participants
Where
1 siteThailand
Study dates
Jan 2016to Jul 2016
How long will I take part?
2 Months
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: renal transplant pateints for more than 1 month

Who may be able to join

  • renal transplant patients patients for more than 1 month

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Bangkok metropolitan administraiton of vajira hospital

    Bangkok, Bangkok, 10170

Other trials in Thailand

About this study

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.

Read the 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.

Being tested
CAVI and FGF-21
Keywords
CAVI, FGF-21, arterial stiffness, renal transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAVI and FGF-21Other

    FGf-21 and CAVI was measured in renal transplant patients group and study correlation with arterial stiffness

Study groups in NCT02704468
Study groupRoleWhat they receive
CAVI and FGF-21renal transplant patients for more than 1 month measured FGF-21 and CAVI
Receives: Other: CAVI and FGF-21

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. association between CAVI and FGF-21 with arterial stiffness in renal transplant patients

    cross sectional study

    Measured: 1 month

Secondary outcomes (1)

  1. association between Hs-CRP,Homocystein with CAVI

    cross sectional study

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704468
Sponsor's protocol ID
085/58
Acronym
CAVIFGF21
Status last verified
Jul 2016
First submitted
29 Feb 2016
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data about CAVI and FGF 21

Publications

  • Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation. 2003 Oct 28;108(17):2154-69. doi: 10.1161/01.CIR.0000095676.90936.80. No abstract available.

    PubMed 14581387

  • An SY, Lee MS, Yi SA, Ha ES, Han SJ, Kim HJ, Kim DJ, Lee KW. Serum fibroblast growth factor 21 was elevated in subjects with type 2 diabetes mellitus and was associated with the presence of carotid artery plaques. Diabetes Res Clin Pract. 2012 May;96(2):196-203. doi: 10.1016/j.diabres.2012.01.004. Epub 2012 Jan 30.

    PubMed 22293928

  • Verbeke F, Marechal C, Van Laecke S, Van Biesen W, Devuyst O, Van Bortel LM, Jadoul M, Vanholder R. Aortic stiffness and central wave reflections predict outcome in renal transplant recipients. Hypertension. 2011 Nov;58(5):833-8. doi: 10.1161/HYPERTENSIONAHA.111.176594. Epub 2011 Sep 6.

    PubMed 21896935

  • Khoshdel AR, Carney SL. Arterial stiffness in kidney transplant recipients: an overview of methodology and applications. Urol J. 2008 Winter;5(1):3-14.

    PubMed 18454420

  • Stehouwer CD, Henry RM, Ferreira I. Arterial stiffness in diabetes and the metabolic syndrome: a pathway to cardiovascular disease. Diabetologia. 2008 Apr;51(4):527-39. doi: 10.1007/s00125-007-0918-3. Epub 2008 Feb 1.

    PubMed 18239908

  • Sun CK. Cardio-ankle vascular index (CAVI) as an indicator of arterial stiffness. Integr Blood Press Control. 2013 Apr 30;6:27-38. doi: 10.2147/IBPC.S34423. Print 2013.

    PubMed 23667317

  • Kim KJ, Lee BW, Kim HM, Shin JY, Kang ES, Cha BS, Lee EJ, Lim SK, Lee HC. Associations between cardio-ankle vascular index and microvascular complications in type 2 diabetes mellitus patients. J Atheroscler Thromb. 2011;18(4):328-36. doi: 10.5551/jat.5983. Epub 2011 Jan 6.

    PubMed 21224525

  • Takaki A, Ogawa H, Wakeyama T, Iwami T, Kimura M, Hadano Y, Matsuda S, Miyazaki Y, Matsuda T, Hiratsuka A, Matsuzaki M. Cardio-ankle vascular index is a new noninvasive parameter of arterial stiffness. Circ J. 2007 Nov;71(11):1710-4. doi: 10.1253/circj.71.1710.

    PubMed 17965489

  • Hayashi K, Sato M, Niimi H, Handa H, Moritake K. [Analysis of the constitutive laws of the vascular wall by finite deformation theory]. Iyodenshi To Seitai Kogaku. 1975 Oct;13(5):293-8. No abstract available. Japanese.

    PubMed 1240535

  • KOTANI, K.; REMALEY, A. T. Cardio-AnkleVascular Index (CAVI) and its Potential Clinical Implications for Cardiovascular Disease. CardiolPharmacol, 2013, 2: 108.

  • Otsuka K, Fukuda S, Shimada K, Suzuki K, Nakanishi K, Yoshiyama M, Yoshikawa J. Serial assessment of arterial stiffness by cardio-ankle vascular index for prediction of future cardiovascular events in patients with coronary artery disease. Hypertens Res. 2014 Nov;37(11):1014-20. doi: 10.1038/hr.2014.116. Epub 2014 Jul 10.

    PubMed 25007768

  • Dobsak P, Soska V, Sochor O, Jarkovsky J, Novakova M, Homolka M, Soucek M, Palanova P, Lopez-Jimenez F, Shirai K. Increased cardio-ankle vascular index in hyperlipidemic patients without diabetes or hypertension. J Atheroscler Thromb. 2015;22(3):272-83. doi: 10.5551/jat.24851. Epub 2014 Oct 22.

    PubMed 25342382

  • Shirai K, Hiruta N, Song M, Kurosu T, Suzuki J, Tomaru T, Miyashita Y, Saiki A, Takahashi M, Suzuki K, Takata M. Cardio-ankle vascular index (CAVI) as a novel indicator of arterial stiffness: theory, evidence and perspectives. J Atheroscler Thromb. 2011;18(11):924-38. doi: 10.5551/jat.7716. Epub 2011 May 31.

    PubMed 21628839

  • Cheng HM, Chuang SY, Sung SH, Yu WC, Pearson A, Lakatta EG, Pan WH, Chen CH. Derivation and validation of diagnostic thresholds for central blood pressure measurements based on long-term cardiovascular risks. J Am Coll Cardiol. 2013 Nov 5;62(19):1780-7. doi: 10.1016/j.jacc.2013.06.029. Epub 2013 Jul 10.

    PubMed 23850921

  • Jin K, LaFevre-Bernt M, Sun Y, Chen S, Gafni J, Crippen D, Logvinova A, Ross CA, Greenberg DA, Ellerby LM. FGF-2 promotes neurogenesis and neuroprotection and prolongs survival in a transgenic mouse model of Huntington's disease. Proc Natl Acad Sci U S A. 2005 Dec 13;102(50):18189-94. doi: 10.1073/pnas.0506375102. Epub 2005 Dec 2.

    PubMed 16326808

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Stiffness, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.

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 1 inclusion and 4 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

association between CAVI and FGF-21 with arterial stiffness in renal transplant patients (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704468, which also lists 27 linked publications.

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 19 Jul 2016.

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