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

Stroke Clinical Trial

— CAVI-J  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859897
• Other study ID #: okayama-1692
• Status: Completed
• Start date: May 2013
• Est. completion date: April 2020

Study information

• Verified date: September 2020
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3026
• Est. completion date: April 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Death
• Infarction
• Myocardial Infarction
• Nonfatal Myocardial Infarction
• Stroke

Locations

Country	Name	City	State
Japan	Okayama University	Okayama

Sponsors (5)

Lead Sponsor	Collaborator
CAVI-J Study Group	Dokkyo Medical University, Ehime University Graduate School of Medicine, Okayama University, Toho University School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in CAVI and cardiovascular events		5 years
Primary	major cardiac events	cardiac death, nonfatal myocardial infarction, stroke	five years
Secondary	all cause mortality, cardiovascular events, and renaly dysfunction	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)	five years

External Links

•   Click here for more information about this study (in Japanese)