This trial is active, not recruiting.

Conditions stroke, cardiovascular death, nonfatal myocardial infarction
Sponsor CAVI-J Study Group
Collaborator Toho University School of Medicine
Start date June 2013
End date June 2019
Trial size 3000 participants
Trial identifier NCT01859897, okayama-1692


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
All subjects will be treated by optimal medical therapy and lifestyle modification.

Primary Outcomes

major cardiac events
time frame: five years

Secondary Outcomes

all cause mortality, cardiovascular events, and renaly dysfunction
time frame: five years

Eligibility Criteria

Male or female participants from 40 years up to 74 years old.

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

Additional Information

Official title A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
Principal investigator Hajime Orimo, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Okayama University.