NCT05632601Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 26 Oct 2022
- Start date
- 25 Apr 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- High blood pressure
- NCT number
- NCT05632601
What you commit to
- Study type: Interventional
- Participants enrolled: 176
- From 25 Apr 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of any of the following:
Other illness
- 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)
Other
- Male sex
- Currently pregnant
Who the study is looking for
- 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
Age in the registry: 25 years to 55 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.