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Completed

NCT Number: NCT04198896

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

incidece of cancers

Other

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

Primary outcomes

  1. inicidence of cancers

    Time frame: through study completion, an average of 3 years

    number of all types of cancers during follow-up periods

Secondary outcomes

  1. all-cause mortality

    Time frame: through study completion, an average of 3 years

    number of all types of death during follow-up periods

Sponsors and collaborators

Lead sponsor

Sakakibara Heart Institute

Other

Registry information

Official study title

Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis

Acronym: SHIP-AC

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2019
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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