A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan (CAVI-J)

September 23, 2020 updated by: CAVI-J Study Group
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3026

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

  • Japan
      • Okayama, Japan, 700-8558
        • Okayama University

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

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primiary care clinic and hospital

Description

Inclusion Criteria:

Patients between 40 and 74 years of age who have either of the following:

  1. Type 2 diabetes mellitus
  2. Metabolic syndrome
  3. Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009
  4. Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
  5. History of coronary artery disease or noncardiogenic cerebral infarction

Exclusion Criteria:

  1. Under 40 years of age or over 74 years of age
  2. An ankle-brachial index less than 0.9
  3. Chronic atrial fibrillation
  4. Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%)
  5. Malignancy
  6. Chronic kidney disease(G4 or G5)according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
  7. chronic dialysis due to renal failure
  8. Taking steroids/immunosuppressants
  9. Hepatocirrhosis

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
Optimal therapy
All subjects will be treated by optimal medical therapy and lifestyle modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major cardiac events
Time Frame: five years
cardiac death, nonfatal myocardial infarction, stroke
five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortality, cardiovascular events, and renaly dysfunction
Time Frame: five years
all cause death, angina pectoris (with revascularization), New incidence of lower limb peripheral arterial disease(including lower limb arteriosclerosis obliterans), Aortic aneurysm, Aortic dissection, Heart failure that requires hospitalization, Deterioration in renal function (dialysis or renal transplantation)
five years

Other Outcome Measures

Outcome Measure
Time Frame
Change in CAVI and cardiovascular events
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

CAVI-J Study Group

Collaborators

Okayama University
Dokkyo Medical University
Ehime University Graduate School of Medicine
Toho University School of Medicine

Investigators

  • Principal Investigator: Hajime Orimo, MD, Kenkoin Clinic

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 (Actual)

May 1, 2013

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • okayama-1692

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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