The Sakakibara Health Integrative Profile Cohort Study

NCT03005834 | Completed

• 1 other identifier: SHIP01
• Study Type: observational
• Target: 32,095
• Locations: 0 countries
• Sites: N/A

Brief Summary

Because of the genetic and traditional commonalities between the underlying causes of atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with atherosclerotic CVD may have a high incidence of cancers when compared with those with non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of improving healthy life expectancy in patients with CVD in our institute.

Conditions

Cancer

Keywords

Atherosclerotic cardiovascular diseases, cancers

Outcome Measures

Primary Outcomes (1)

• incidence of cancers

  July, 2014

Secondary Outcomes (1)

• any cause mortality

  July, 2014

Study Arms (2)

Atherosclerotic CVD

Atherosclerotic cardiovascular diseases (CVD) included coronary artery diseases, aortic diseases and peripheral artery diseases.

Other: incidence of cancers

Non-atherosclerotic CVD

Non-atherosclerotic cardiovascular diseases (CVD) were any CVD except atherosclerotic CVD and congenital CVD.

Other: incidence of cancers

Interventions

incidence of cancers OTHER

With a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified.

Atherosclerotic CVD; Non-atherosclerotic CVD

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

A total of 36,151 patients (58% male, 61±23 years) with any cardiovascular diseases (CVD) enrolled in the SHIP cohort study between June 2006 and July 2014.

You may qualify if:

• Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study after excluding 4,056 patients with known cancers and/or congenital CVD.

You may not qualify if:

• We excluded 245 patients who had already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD including Marfan syndrome.

Sponsors & Collaborators

• Sakakibara Heart Institute: lead

Related Publications (1)

• Suzuki M, Tomoike H, Sumiyoshi T, Nagatomo Y, Hosoda T, Nagayama M, Ishikawa Y, Sawa T, Iimuro S, Yoshikawa T, Hosoda S. Incidence of cancers in patients with atherosclerotic cardiovascular diseases. Int J Cardiol Heart Vasc. 2017 Sep 14;17:11-16. doi: 10.1016/j.ijcha.2017.08.004. eCollection 2017 Dec.

  PMID: 28948207 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Makoto Suzuki, MD

  Sakakibara Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1020 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Cardiology

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: December 29, 2016
• Study Start: June 1, 2006
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share