Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment

September 19, 2018 updated by: Bui My Hanh, Hanoi Medical University
This study aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The eligible patients were prospectively monitored to evaluate CAVI in hypertension treatment for every 3 months. All participants will be asked directly medical history, clinical examination and performed blood pressure measurement thoroughly. All clinical information will be retained in medical record.

Description

Inclusion Criteria:

  • Patients have never been diagnosed with hypertension.
  • Patients have been diagnosed with primary hypertension, but not take any treatment

Exclusion Criteria:

  • Cases with non-primary hypertension or suffering from cardiovascular complications such as myocardial infarction, cerebral stroke, vascular disease, severe heart failure (EF<1) in the time of measurement.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypertension group

All adult patients (above 18 year of age) were recruited between May, 2016 and June 2017, at Duc Giang General Hospital. The inclusion criteria are as followed:

  • Patients have never been diagnosed with hypertension.
  • Has been diagnosed with primary hypertension, but not take any treatment.
Procedure: Hypertension outpatient treatment
Patients who have been diagnosed with primary hypertension and meet the conditions of the study will receive outpatient treatment
Control group
A group of normal people with the similar age to hypertension group was recruited as control group at the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAVI score in hypertension group after one year of treatment
Time Frame: 1 year
CAVI score of patients who achieved their target blood pressure after one year of hypertension treatment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between CAVI and smoking status
Time Frame: 1 year
Evaluating correlation between CAVI score and smoking status in hypertension patients
1 year
Correlation between CAVI and overweight status
Time Frame: 1 year
Evaluating correlation between CAVI score and overweight status in hypertension patients
1 year
Correlation between CAVI and diabetes status
Time Frame: 1 year
Evaluating correlation between CAVI score and diabetes status in hypertension patients
1 year
Correlation between CAVI and dislypidemia status
Time Frame: 1 year
Evaluating correlation between CAVI score and dyslipidemia status in hypertension patients
1 year

Collaborators and Investigators

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

Sponsor

Hanoi Medical University

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 (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (ACTUAL)

September 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMU16225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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