Active — Not RecruitingNot Applicable

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

Canada176 participantsStarted 2023-04-25

Plain-language 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.

Who can participate

Age range

25 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demographics questionnaire

Timeframe: 18 months

Medical History Questionnaire

Timeframe: 18 months

General Anxiety Disorder-7 (GAD-7)

Timeframe: 18 months

Patient Health Questionnaire (PHQ)-9

Timeframe: 18 months

Perceived Stress Scale (PSS)

Timeframe: 18 months

The Index of Spouse Abuse (ISA)

Timeframe: 18 months

Childhood Trauma Questionnaire (CTQ)

Timeframe: 18 months

PTSD Checklist-5 (PCL-5)

Timeframe: 18 months

Trial details

NCT IDNCT05632601

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Cardiovascular Diseases trials

Plain-language summary

Who can participate

Age range

25 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Demographics questionnaire

Timeframe: 18 months

Medical History Questionnaire

Timeframe: 18 months

General Anxiety Disorder-7 (GAD-7)

Timeframe: 18 months

Patient Health Questionnaire (PHQ)-9

Timeframe: 18 months

Perceived Stress Scale (PSS)

Timeframe: 18 months

The Index of Spouse Abuse (ISA)

Timeframe: 18 months

Childhood Trauma Questionnaire (CTQ)

Timeframe: 18 months

PTSD Checklist-5 (PCL-5)

Timeframe: 18 months