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Not Yet Recruiting
NCT05632601
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Conditions: Cardiovascular Diseases
Sex: Female
Ages: 25 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 210
Sponsor: Ottawa Heart Institute Research Corporation
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 Criteria
Inclusion Criteria:Female SexBetween 25-55 years of ageOntario resident with a valid OHIP cardA prior or current diagnosis of:Pre-eclampsia, eclampsia, gestational hypertensionGestational diabetesPrimary 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 cancerORNo prior history of sex-specific or female-predominant risk factors outlined in the SSR groupExclusion Criteria:Male sexCurrently pregnantPrior 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 CVDNeurodegenerative disease known to affect the heart (e.g., muscular dystrophy)Untreated serious mental illness (e.g., untreated psychosis)
Source: ClinicalTrials.gov (NCT05632601). StuddyBuddy aggregates publicly available trial information.