A study on women's cardiovascular risk factors
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
This study is testing a new way to predict heart attack and stroke risks in women by looking at factors unique to them, like pre-eclampsia and polycystic ovarian syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | Female |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05632601 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a women-specific cardiovascular risk score to predict serious cardiovascular outcomes such as heart attacks and strokes. It will focus on female-specific risk factors, including conditions like pre-eclampsia and polycystic ovarian syndrome, and will recruit a diverse sample of women from Ontario. The study will utilize advanced imaging techniques like PET scans to assess cardiovascular health and will be the first of its kind to longitudinally examine these issues in women. This pilot study serves as a preparatory step for a larger cohort study.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-55 residing in Ontario with specific female-related cardiovascular risk factors.
Not a fit: Patients with a prior diagnosis of cardiovascular disease or currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular risk assessment and prevention strategies specifically tailored for women.
How similar studies have performed: While there have been studies on cardiovascular disease in women, this approach focusing specifically on female-specific risk factors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Male sex * Currently pregnant * Prior diagnosis of any of the following: * CVD including coronary heart disease, heart failure, congenital heart disease, stroke/transient ischemic attack, valvular heart disease, peripheral vascular disease, aortapathy, atrial fibrillation or flutter, other CVD * Neurodegenerative disease known to affect the heart (e.g., muscular dystrophy) * Untreated serious mental illness (e.g., untreated psychosis)
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kerri-Anne Mullen, PhD — Uohi
- Study coordinator: Kerri-Anne Mullen, PhD
- Email: kmullen@ottawaheart.ca
- Phone: 6136967000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.