Clinical trial · Interventional
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group
- description
- * Blood sample * Questionnaires * Arterial stiffness assessment * Transthoracic Echocardiogram * Coronary Computed Tomography Angiography (CTA) * Cardiac Positron Emission Tomography (PET)
- interventionNames
- Diagnostic Test: PET scan
- type
- NO_INTERVENTION
- label
- Sex-Specific Risk factor group and Age-Matched Control Group
- description
- * Blood sample * Questionnaires * Arterial stiffness assessment
Primary outcomes (18)
- measure
- Demographics questionnaire
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available