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

NCT04198896 | Completed DMC

• 1 other identifier: SHIP03
• Study Type: observational
• Target: 8,856
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancers; Atheroscleroses, Coronary; Atherosclerosis of Artery

Keywords

Atherosclerosis, cancers

Outcome Measures

Primary Outcomes (1)

• inicidence of cancers

  number of all types of cancers during follow-up periods

  through study completion, an average of 3 years

Secondary Outcomes (1)

• all-cause mortality

  through study completion, an average of 3 years

Study Arms (2)

CAD-only

patients with diagnosed coronary artery diseases (CAD) without any other atherosclerotic cardiovascuar diseases at the entry of SHIP

Other: incidece of cancers

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

Interventions

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

CAD with poly-arterial diseases; CAD-only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

same as eligibility criteria

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakakibara Heart Institute: lead

Related Publications (1)

• Suzuki M, Tomoike H, Dai Z, Hosoda T, Sumiyoshi T, Hosoda S, Isobe M. Polyvascular Disease and the Incidence of Cancer in Patients with Coronary Artery Disease. JMA J. 2022 Oct 17;5(4):498-509. doi: 10.31662/jmaj.2022-0098. Epub 2022 Sep 26.

  PMID: 36407071 DERIVED

MeSH Terms

Conditions

Neoplasms; Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1095 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Cardiology

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2009
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share