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The Sakakibara Health Integrative Profile Cohort Study

NCT ID: NCT03005834

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32095 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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The SHIP cohort study was launched in 2006 for the purpose of improving healthy life expectancy in patients with any cardiovascular diseases (CVD) who were admitted to the Sakakibara Heart Institute. The study used a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD including cancers, via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year. Organ sites of cancers were also identified whenever possible. The study sorted any diagnoses of CVD into nine categories, namely coronary artery diseases, aortic diseases, peripheral artery diseases, myocardial diseases, unclassified or any-cause heart failure, valvular heart diseases, arrhythmias, congenital CVD, and others. For example, if a patient had a couple of diseases, he or she had a plural category. Cerebrovascular diseases were included in the category of 'others' because of the mixed cause for the diseases such as embolic strokes, lacunar infarction, cardio-embolic strokes, and hemorrhagic strokes, etc. Atherosclerotic CVD were defined by the presence of one or more of the following three diseases: coronary artery diseases, aortic diseases and peripheral artery diseases. With regard to the detail of coronary artery diseases, there were acute coronary syndromes, previous myocardial infarction and stable ischemic heart diseases. Aortic diseases consisted of acute aortic syndromes and aortic aneurysms. Non-atherosclerotic CVD were defined as any CVD except atherosclerotic and congenital CVD. The SHIP cohort study also handled to define lifestyle related diseases when confirmed a diagnosis of one or more of the presence of hypertension, dyslipidemia, diabetes mellitus and chronic kidney disease in accordance with the universal criteria. A history of tobacco smoking was also identified. Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, 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. Thus, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study.Our study was conducted in two steps to assess an incidence of cancers in patients with acquired CVD. The first step consisted of a comparison between those with atherosclerotic CVD and non-atherosclerotic CVD with regard to an incidence of cancers. The second step determined the association between a singular presence versus a plural presence of atherosclerotic CVD and an incidence of cancers.

Conditions

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Cancer

Keywords

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Atherosclerotic cardiovascular diseases, cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atherosclerotic CVD

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

incidence of cancers

Intervention Type 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.

Non-atherosclerotic CVD

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

incidence of cancers

Intervention Type 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.

Interventions

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incidence of cancers

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakakibara Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Makoto Suzuki

Principal Investigator, Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Makoto Suzuki, MD

Role: PRINCIPAL_INVESTIGATOR

Sakakibara Heart Institute

References

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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.

Reference Type DERIVED
PMID: 28948207 (View on PubMed)

Other Identifiers

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SHIP01

Identifier Type: -

Identifier Source: org_study_id