The Sakakibara Health Integrative Profile of Atherosclerotic-Carcinogenesis Hypothesis (SHIP-AC)

Completed

• Conditions: Atheroscleroses, Coronary; Atherosclerosis of Artery; Cancers
• Interventions: Other: incidece of cancers

• Registration Number: NCT04198896
• Lead Sponsor: Sakakibara Heart Institute

Brief Summary

As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis in cancer developments. In the present study, to address our hypothesis that cancer developments may come with a strength of atherosclerosis, we traced an incidence of cancers in a total of 8,856 patients with coronary artery diseases (CAD) for a median follow-up of 1,095 days (interquartile range, 719-1,469 days) using the Sakakibara Health Integrative Profile (SHIP) database.

Detailed Description

In accordance with a presence or absence of poly-arterial diseases such as aortic and/or peripheral artery diseases as an indicator of a strength of atherosclerosis, an incidence of cancers and all-cause death in two cohorts of 8,140 patients with CAD-only and 716 with CAD with poly-arterial diseases were evaluated to track an incidence of cancers and ali-cause mortality during median follou-up periods of 3 to 4 years.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2019-12
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8856

Inclusion Criteria

• patients with diagnosed coronary artery diseases without a dignosis of cancers at the entry of SHIP between January 2009 and July 2014.

Exclusion Criteria

• patients with diagnosed coronary artery diseases who had already been diagnosed with any cancers at the time of enrollment in the SHIP, and who were not followed-up after the entry of SHIP.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAD-only	incidece of cancers	patients with diagnosed coronary artery diseases (CAD) without any other atherosclerotic cardiovascuar diseases at the entry of SHIP
CAD with poly-arterial diseases	incidece of cancers	patients with diagnosed coronary artery diseases (CAD) with other atherosclerotic cardiovascuar diseases such as any of aortic and/or peripheral artery diseases at the entry of SHIP

Primary Outcome Measures

Name	Time	Method
inicidence of cancers	through study completion, an average of 3 years	number of all types of cancers during follow-up periods

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	through study completion, an average of 3 years	number of all types of death during follow-up periods