CClinicalTrials.gg
CompletedNCT04198896SHIP-ACUpdated Dec 18, 2019

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

An observational study in Cancers, Atheroscleroses, Coronary and Atherosclerosis of Artery, sponsored by Sakakibara Heart Institute. Completed. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by Sakakibara Heart Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8,856
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancers
  • Atheroscleroses, Coronary
  • Atherosclerosis of Artery

Keywords

  • Atherosclerosis, cancers
03

In context

Carcinogenesis

39 studies on the registry are indexed under Carcinogenesis; 10 are open to participants now.

This study's enrollment of 8,856 is above the median of 278 across 22 observational studies indexed under Carcinogenesis.

Browse Carcinogenesis studies →

Lead sponsor

Sakakibara Heart Institute is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

same as eligibility criteria

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8,856 participants (actual)
Target follow-up
1095 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherincidece 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

06

What researchers measure

Primary outcomes

  1. inicidence of cancers

    number of all types of cancers during follow-up periods

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

Secondary outcomes

  1. all-cause mortality

    number of all types of death during follow-up periods

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — After completed, the data will be shared with simlar study investigators over the world

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04198896
Lead sponsor
Sakakibara Heart Institute
Responsible party
Makoto Suzuki (Director, Department of Cardiology, Sakakibara Heart Institute) — Principal investigator
First posted
Dec 13, 2019
Start date
Jan 2009
Primary completion
Oct 2019
Completion
Oct 2019
Last update
Dec 18, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion