Kyushu Prevention Study of Atherosclerosis

Not Applicable

• Conditions: Atherosclerosis

• Registration Number: JPRN-UMIN000011245
• Lead Sponsor: Kyushu University

Brief Summary

This observational study included 3981 diabetic patients (61.0(SD=11.8) years of age, 59.4% men), registered in the Kyushu Prevention Study for Atherosclerosis. Patients were divided into 3 groups according to the value of ABI at baseline:ABI <0.90 (abnormal ABI:354 patients), 0.91<ABI<0.99 (borderline ABI:333 patients), and 1.00<ABI<1.40 (normal ABI:3294 patients). Cumulative incidence of all-cause death was significantly higher in patients with abnormal and borderline ABI than in those with normal ABI (34.4% vs.13.5%, P<0.0001 and 26.1% vs.13.5%, P<0.0001, respectively). In multivariate analysis, the risks for all-cause death in patients with abnormal ABI (HR:2.16; 95%CI:1.46-3.14; P=0.0002) and borderline ABI (HR:1.78; 95%CI:1.14-2.70; P=0.01) were significantly higher than in those with normal ABI. The incidence of PAD was remarkably higher in patients with borderline ABI than in those with normal ABI (32.2% vs.9.0%, P<0.0001). After adjustment, the risk for PAD was significantly higher in patients with borderline ABI than in those with normal ABI (HR:3.10; 95%CI:1.90-4.95; P<0.0001). Borderline ABI in diabetic patients was associated with significantly higher risks for mortality and PAD compared with normal ABI.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Not provided

Exclusion Criteria

Patients under 20 and over 85 years old.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause death

Secondary Outcome Measures

Name	Time	Method
cardiovascular event cardiovascular death PWV value ABI value