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

Sponsor
CAVI-J Study Group (Other)
Overall Status
Completed
CT.gov ID
NCT01859897
Collaborator
Toho University School of Medicine (Other), Ehime University Graduate School of Medicine (Other), Dokkyo Medical University (Other), Okayama University (Other)
3,026
Enrollment
1
Location
83
Actual Duration (Months)
36.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3026 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
    Actual Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Optimal therapy

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

    Outcome Measures

    Primary Outcome Measures

    1. major cardiac events [five years]

      cardiac death, nonfatal myocardial infarction, stroke

    Secondary Outcome Measures

    1. all cause mortality, cardiovascular events, and renaly dysfunction [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)

    Other Outcome Measures

    1. Change in CAVI and cardiovascular events [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Okayama University Okayama Japan 700-8558

    Sponsors and Collaborators

    • CAVI-J Study Group
    • Toho University School of Medicine
    • Ehime University Graduate School of Medicine
    • Dokkyo Medical University
    • Okayama University

    Investigators

    • Principal Investigator: Hajime Orimo, MD, Kenkoin Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    CAVI-J Study Group, CAVI-J study Group, Okayama University
    ClinicalTrials.gov Identifier:
    NCT01859897
    Other Study ID Numbers:
    • okayama-1692
    First Posted:
    May 22, 2013
    Last Update Posted:
    Sep 25, 2020
    Last Verified:
    Sep 1, 2020
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Sep 25, 2020