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

Atherosclerosis of Artery Clinical Trial

— SHIP-AC  

Official title:

Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198896
• Other study ID #: SHIP03
• Status: Completed
• Start date: January 2009
• Est. completion date: October 2019

Study information

• Verified date: December 2019
• Source: Sakakibara Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8856
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atheroscleroses, Coronary
• Atherosclerosis
• Atherosclerosis of Artery
• Cancers
• Carcinogenesis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sakakibara Heart Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inicidence of cancers	number of all types of cancers during follow-up periods	through study completion, an average of 3 years
Secondary	all-cause mortality	number of all types of death during follow-up periods	through study completion, an average of 3 years