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

NCT01859897 | Completed DMC

• 1 other identifier: okayama-1692
• Study Type: observational
• Target: 3,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cardiovascular Death; Nonfatal Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• major cardiac events

  cardiac death, nonfatal myocardial infarction, stroke

  five years

Secondary Outcomes (1)

• all cause mortality, cardiovascular events, and renaly dysfunction

  five years

Other Outcomes (1)

• Change in CAVI and cardiovascular events

  5 years

Study Arms (1)

Optimal therapy

All subjects will be treated by optimal medical therapy and lifestyle modification.

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primiary care clinic and hospital

You may qualify if:

• 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

You may not qualify if:

• 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%)
• Malignancy
• 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

Sponsors & Collaborators

• CAVI-J Study Group: lead
• Toho University: collaborator
• Ehime University Graduate School of Medicine: collaborator
• Dokkyo Medical University: collaborator
• Okayama University: collaborator

Study Sites (1)

Okayama University

Okayama, 700-8558, Japan

Location

Related Publications (1)

• Miyoshi T, Ito H, Shirai K, Horinaka S, Higaki J, Yamamura S, Saiki A, Takahashi M, Masaki M, Okura T, Kotani K, Kubozono T, Yoshioka R, Kihara H, Hasegawa K, Satoh-Asahara N, Orimo H; CAVI-J (Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan) investigators *. Predictive Value of the Cardio-Ankle Vascular Index for Cardiovascular Events in Patients at Cardiovascular Risk. J Am Heart Assoc. 2021 Aug 17;10(16):e020103. doi: 10.1161/JAHA.120.020103. Epub 2021 Aug 7.

  PMID: 34369198 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hajime Orimo, MD

  Kenkoin Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CAVI-J study Group

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: April 1, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

JP (1)