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

Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis

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.

Study Overview

• Status: Completed
• Conditions: Atheroscleroses, Coronary; Atherosclerosis of Artery; Cancers
• Intervention / Treatment: Other: incidece of cancers

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 Type: Observational
• Enrollment (Actual): 8856

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

same as eligibility criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAD-only; patients with diagnosed coronary artery diseases (CAD) without any other atherosclerotic cardiovascuar diseases at the entry of SHIP	Other: incidece of cancers; With a continuous surveillance system to track all subsequent incidents of cardiovascular diseases and/or non-cardiovascular diseases via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified
CAD with poly-arterial diseases; 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	Other: incidece of cancers; With a continuous surveillance system to track all subsequent incidents of cardiovascular diseases and/or non-cardiovascular diseases via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inicidence of cancers	number of all types of cancers during follow-up periods	through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	number of all types of death during follow-up periods	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Sakakibara Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Atherosclerosis, cancers
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms; Neoplastic Processes; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Carcinogenesis
• Other Study ID Numbers: SHIP03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After completed, the data will be shared with simlar study investigators over the world

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No