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

Completed

• Conditions: Stroke; Cardiovascular Death; Nonfatal Myocardial Infarction

• Registration Number: NCT01859897
• Lead Sponsor: CAVI-J Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Primary Completion: 2019-06
• Study Completion: 2020-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3026

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major cardiac events	five years	cardiac death, nonfatal myocardial infarction, stroke

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Okayama University; 🇯🇵 Okayama, Japan