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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01859897

Acronym

CAVI-J

Enrollment

3026

Registered

2013-05-22

Start date

2013-05-31

Completion date

2020-04-30

Last updated

2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Death, Nonfatal Myocardial Infarction, Stroke

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
major cardiac events	five years	cardiac death, nonfatal myocardial infarction, stroke

Secondary

Measure	Time frame	Description
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

Measure	Time frame
Change in CAVI and cardiovascular events	5 years

Countries

Japan

Outcome results