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

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ClinicalTrials.gov Identifier: NCT03680313
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Bui My Hanh, Hanoi Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hypertension Procedure: Hypertension outpatient treatment

Study Design
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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Correlation between CAVI and smoking status [ Time Frame: 1 year ]
    Evaluating correlation between CAVI score and smoking status in hypertension patients

  2. Correlation between CAVI and overweight status [ Time Frame: 1 year ]
    Evaluating correlation between CAVI score and overweight status in hypertension patients

  3. Correlation between CAVI and diabetes status [ Time Frame: 1 year ]
    Evaluating correlation between CAVI score and diabetes status in hypertension patients

  4. Correlation between CAVI and dislypidemia status [ Time Frame: 1 year ]
    Evaluating correlation between CAVI score and dyslipidemia status in hypertension patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bui My Hanh, Director, Science Research and International Cooperation Unit, Hanoi Medical University
ClinicalTrials.gov Identifier: NCT03680313    
Other Study ID Numbers: HMU16225
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bui My Hanh, Hanoi Medical University:
Cardio-ankle vascular index (CAVI)
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases