NCT03938155

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2019Oct 2026

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

May 2, 2019

Last Update Submit

January 25, 2021

Conditions

Cardiovascular Disease (CVD)Cardiovascular Risk FactorVascular Stiffness

Keywords

femalehumansagedcardiovascular systemcardiovascular diseasescardiovascular diseases/epidemiologyearly diagnosisfrailtyfrailty elderlyprospective studiesManitoba/epidemiologygastrointestinal microbiomecohort studiescause of deathrisk assessmentbiomarkersrisk factorspulse wave analysisaccelerometryexercisephysical fitnessgendersexwomenearly detectionscreening program

Outcome Measures

Primary Outcomes (8)

  • Ischemic heart disease

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Acute myocardial infarction

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Stroke

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Transient ischemic attack

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Percutaneous coronary intervention

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Coronary artery bypass surgery

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Congestive heart failure

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

  • Future diagnosis of hypertension

    Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.

    5 years post-screening

Eligibility Criteria

Age55 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One-thousand female participants 55 years of age or older will be recruited through a convenience sample method. Namely, we will utilize radio interviews on popular local stations to discuss the study as well as presentations at community events related to cardiovascular health. Articles will be published in a local newspaper and poster advertisements will also be placed in key locations related to the Winnipeg Regional Health Authority. Potential study participants interested in participating will contact the research coordinator in person, by email, or via telephone.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital Albrechtsen Research Centre

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

Related Publications (1)

  • Rose AV, Boreskie KF, Hay JL, Thompson L, Arora RC, Duhamel TA. Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a prospective, observational cohort study. BMJ Open. 2021 May 25;11(5):e044227. doi: 10.1136/bmjopen-2020-044227.

    PMID: 34035097DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

This study involves the collection of blood and stool samples to: * characterize gut microbiota * analyze triglycerides, HDL/LDL cholesterol and blood glucose * metabolomics * Biomarker analysis

MeSH Terms

Conditions

Cardiovascular DiseasesDiseaseFrailtyMotor ActivityCoitus

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSexual Behavior

Central Study Contacts

Todd Duhamel, PhD

CONTACT

204-235-3589tduhamel@sbrc.ca

Kevin Boreskie, MSc

CONTACT

204-480-1815kboreskie@sbrc.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion (Estimated)

October 1, 2026

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Initial WARM Hearts study data collection is expected to be complete in late 2021. Deidentified data will be available 6-months after that. Researchers wishing to access data should contact Dr. Todd Duhamel (tduhamel@sbrc.ca; orcid.org/0000-0001-8467-4800). A data dictionary will be available upon request. An itemized list of the data you are requesting with a brief proposal that outlines your justification, hypotheses, and proposed analyses will be required. Since biological samples represent a finite resource, the proposed analyses will be considered with regard to novelty, feasibility, and ethical approval. A Data Sharing Transfer Agreement or a Material Transfer Agreement must be signed and adhered to by collaborating parties and their respective institutions. Electronic data formats will be made available through the University of Manitoba Dataverse repository, following policies and procedures consistent with Tri-Council requirements.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Biological samples in the biobank will be stored for a maximum of 10 years.

Locations

CA(1)