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

What this trial studies

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 in scope

• Cardiovascular Diseases

Interventions

• PET scan (Diagnostic Test) — PET scan

Who can join

Women only · Ages 25 Years to 55 Years · Accepts healthy volunteers.

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)

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-04-25
• Primary completion: 2026-05
• Last update posted: 2026-05-08
• First posted: 2022-11-30

Sponsor & contact

Lead sponsor: Ottawa Heart Institute Research Corporation (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Demographics questionnaire (18 months)
  Demographics and socioeconomic information
• Medical History Questionnaire (18 months)
  Past, present medical history, medication, and women's health related information
• General Anxiety Disorder-7 (GAD-7) (18 months)
  This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
• Patient Health Questionnaire (PHQ)-9 (18 months)
  Several days = 1 More than half the days = 2 Nearly every day = 3 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
• Perceived Stress Scale (PSS) (18 months)
  PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.