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NCT Number: NCT01859897

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Death Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Nonfatal Myocardial Infarction Vascular Diseases

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Okayama University

Okayama, 700-8558, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Type 2 diabetes mellitus
  • Metabolic syndrome
  • 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
  • Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
  • History of coronary artery disease or noncardiogenic cerebral infarction

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. major cardiac events

    Time frame: five years

    cardiac death, nonfatal myocardial infarction, stroke

Secondary outcomes

  1. 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)

Other outcomes

  1. Change in CAVI and cardiovascular events

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

CAVI-J Study Group

Other

Collaborators

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

Registry information

Acronym: CAVI-J

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
May 22, 2013
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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