Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The full HER CROWN will be a prospective cohort study to propose a novel, women-specific cardiovascular risk score/ algorithm in the prediction of hard cardiovascular outcomes (myocardial infarction, unstable angina, coronary revascularization, stroke, total and cardiovascular mortality). This future study will be the first longitudinal cohort study, to our knowledge, that is focused entirely on researching the pathophysiology and natural history of cardiovascular disease in women with known female-specific risk factors. Further, the investigators are aiming to recruit a sample that is representative of the ethnic distribution in Canada. The proposed pilot study is a feasibility study as an essential preparatory step for HER CROWN.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 55
Healthy Volunteers: t
View:

• Female Sex

• Between 25-55 years of age

• Ontario resident with a valid OHIP card

⁃ A prior or current diagnosis of:

• Pre-eclampsia, eclampsia, gestational hypertension

• Gestational diabetes

• Primary ovarian insufficiency (menopause \< age 40)

• Early menopause (menopause between ages 40-45)

• Polycystic ovarian syndrome (PCOS)

• Rheumatologic inflammatory disorders (Lupus, Rheumatoid Arthritis, Psoriatic Arthritis)

• Breast cancer

⁃ OR

⁃ No prior history of sex-specific or female-predominant risk factors outlined in the SSR group

Locations
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Kerri-Anne Mullen, PhD
kmullen@ottawaheart.ca
6136967000
Backup
Carolyn Van Dam
CVandam@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2025-05
Participants
Target number of participants: 210
Treatments
Experimental: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group
* Blood sample~* Questionnaires~* Arterial stiffness assessment~* Transthoracic Echocardiogram~* Coronary Computed Tomography Angiography (CTA)~* Cardiac Positron Emission Tomography (PET)
No_intervention: Sex-Specific Risk factor group and Age-Matched Control Group
* Blood sample~* Questionnaires~* Arterial stiffness assessment
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov