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Clinical Trials/NCT01859897
NCT01859897
Completed
Not Applicable

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

CAVI-J Study Group1 site in 1 country3,026 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
CAVI-J Study Group
Enrollment
3026
Locations
1
Primary Endpoint
major cardiac events
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
April 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CAVI-J Study Group
Responsible Party
Sponsor Investigator
Principal Investigator

CAVI-J Study Group

CAVI-J study Group

Okayama University

Eligibility Criteria

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%)
  • 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

Outcomes

Primary Outcomes

major cardiac events

Time Frame: five years

cardiac death, nonfatal myocardial infarction, stroke

Secondary Outcomes

  • all cause mortality, cardiovascular events, and renaly dysfunction(five years)

Study Sites (1)

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