Recruiting

Observational Study

Sponsor:

St. Boniface Hospital

Code:

NCT03938155

Conditions

Cardiovascular Disease (CVD)

Cardiovascular Risk Factor

Vascular Stiffness

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The main objective of this study is to test the ability of novel cardiovascular disease (CVD) prognostic tools to identify women at risk for future CVD. We plan to establish a cardiovascular health screening program at the St. Boniface Hospital and to test the efficacy of these tests for predicting adverse cardiovascular outcomes amongst a cohort of 1000 Manitoban women aged 55 years and older in the 5-year period after screening.

A second purpose of this project is to identify novel CVD biomarkers that may indicate a person is at risk for cardiovascular disease. Therefore, we plan to ask participants for permission to collect and store a sample of both their blood and stool for future research.

Conditions

Cardiovascular Disease (CVD)

Cardiovascular Risk Factor

Vascular Stiffness

Study ID

NCT03938155

Start date

Oct 1, 2019

Status verified date

Jan, 2021

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • women aged 55 and older
  • possess a Manitoba Personal Health Information Number

Exclusion Criteria:

Previous hospitalization or treatment for:

  • Ischemic heart disease
  • Acute myocardial infarction
  • Stroke/Transient ischemic attack
  • Percutaneous coronary intervention
  • Coronary artery bypass surgery
  • Congestive heart failure
  • Peripheral artery disease
  • Congenital heart defects
  • Arrhythmia

Additional exclusion:

  • Medical advice against physical activity
  • Previous participant in the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease (NCT02863211)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Ischemic heart disease [ Time Frame: 5 years post-screening ]
  • Acute myocardial infarction [ Time Frame: 5 years post-screening ]
  • Stroke [ Time Frame: 5 years post-screening ]
  • Transient ischemic attack [ Time Frame: 5 years post-screening ]
  • Percutaneous coronary intervention [ Time Frame: 5 years post-screening ]
  • Coronary artery bypass surgery [ Time Frame: 5 years post-screening ]
  • Congestive heart failure [ Time Frame: 5 years post-screening ]
  • Future diagnosis of hypertension [ Time Frame: 5 years post-screening ]

Central Contacts and Locations

Central contacts

Todd Duhamel, PhD

204-235-3589tduhamel@sbrc.ca

Kevin Boreskie, MSc

204-480-1815kboreskie@sbrc.ca

Locations

St. Boniface Hospital Albrechtsen Research Centre

Recruiting

Winnipeg, Manitoba, Canada, R2H2A6

Contacts

Todd Duhamel, PhD

204-235-3589tduhamel@sbrc.ca

Kevin Boreskie, MSc

204-480-1815kboreskie@sbrc.ca

More Information

Sponsor

St. Boniface Hospital

Last update posted

Jan 28, 2021

Last verified

Jan, 2021

Keywords

  • female
  • humans
  • aged
  • cardiovascular system
  • cardiovascular diseases
  • cardiovascular diseases/epidemiology
  • early diagnosis
  • frailty
  • frailty elderly
  • prospective studies
  • Manitoba/epidemiology
  • gastrointestinal microbiome
  • cohort studies
  • cause of death
  • risk assessment
  • biomarkers
  • risk factors
  • pulse wave analysis
  • accelerometry
  • exercise
  • physical fitness
  • gender
  • sex
  • women
  • early detection
  • screening program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2021-01-28.