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

NCT05632601 | Active Not Recruiting

• 1 other identifier: 20220586-01H
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

cardiovascular disease; sex-specific risk factor; hypertensive disorder of pregnancy; Early menopause; Polycystic ovarian syndrome; Rheumatologic inflammatory disorders; breast cancer; gestational diabetes; Primary ovarian insufficiency

Outcome Measures

Primary Outcomes (18)

• Demographics questionnaire

  Demographics and socioeconomic information

  18 months

• Medical History Questionnaire

  Past, present medical history, medication, and women's health related information

  18 months

• General Anxiety Disorder-7 (GAD-7)

  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

  18 months

• Patient Health Questionnaire (PHQ)-9

  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

  18 months

• Perceived Stress Scale (PSS)

  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 PSS 10 item scale.

  18 months

• The Index of Spouse Abuse (ISA)

  Both the ISA-P and ISA-NP scores range from 0 to 100 where a low score indicates the relative absence of abuse and the higher scores represent the presence of a greater degree or amount of abuse.

  18 months

• Childhood Trauma Questionnaire (CTQ)

  Responses are measured on a 5-point Likert scale (1 = never true, 2 = rarely true, 3 = sometimes true, 4 = often true, 5 = very often true). Each subscale is represented by five questions with a score range from 5 to 25; scores fall into four categories: none to low trauma exposure, low to moderate trauma exposure, moderate to severe trauma exposure and severe to extreme trauma exposure for each scale.

  18 months

• PTSD Checklist-5 (PCL-5)

  Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80). 0 = Not at all 1 = A little bit 2 = Moderately 3 = Quite a bit 4 = Extremely

  18 months

• SF-12

  SF-12v2 items are scored so that a higher score indicates a better health state. For example, functioning items are scored so that a high score indicates better functioning, and the pain item is scored so that a high score indicates freedom from pain. After data entry, items are scored in three steps: 1. item recoding for the four items that require recoding; 2. computing scale scores by summing across items in the same scale (raw scale scores); and, 3. transforming raw scale scores to a 0-100 scale (transformed scale scores).

  18 months

• Substance use questionnaire

  Nicotine, alcohol, cannabis use measure questionnaire. No score.

  18 months

• International Physical Activity Questionnaire (IPAQ)

  Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level. Scoring a MODERATE level of physical activity on the IPAQ means you are doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days. Scoring a LOW level of physical activity on the IPAQ means that you are not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.

  18 months

• The Newest Vital Sign (NVS)

  Score by giving 1 point for each correct answer (maximum 6 points). Score of 0-1 suggests high likelihood (50% or more) of limited literacy. Score of 2-3 indicates the possibility of limited literacy. Score of 4-6 almost always indicates adequate literacy.

  18 months

• Arterial tonometry

  Arterial stiffness and arterial age

  18 months

• Coronary CTA

  Coronary artery calcium, plaque presence and plaque characteristics

  18 months

• Cardiac PET

  Coronary perfusion and microvascular function

  18 months

• Transthoracic echocardiography

  Cardiac structure and function

  18 months

• Blood work

  CBC, electrolytes, creatinine, fasting lipids, fasting glucose, HbA1c, hs-troponin, NT-proBNP, Lipoprotein (a), LH, FSH, estradiol, progesterone, additional sample for biobanking βhCG test for subsamples participating in PET and Coronary CTA

  18 months

• Satisfaction Questionnaire

  participant satisfaction and acceptability questionnaire. No score.

  18 months

Study Arms (2)

Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group

EXPERIMENTAL

* Blood sample * Questionnaires * Arterial stiffness assessment * Transthoracic Echocardiogram * Coronary Computed Tomography Angiography (CTA) * Cardiac Positron Emission Tomography (PET)

Diagnostic Test: PET scan

Sex-Specific Risk factor group and Age-Matched Control Group

NO INTERVENTION

* Blood sample * Questionnaires * Arterial stiffness assessment

Interventions

PET scan DIAGNOSTIC_TEST

PET scan

Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Gender Eligibility Details: Female sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• No prior history of sex-specific or female-predominant risk factors outlined in the SSR group

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Toxemia; Primary Ovarian Insufficiency; Polycystic Ovary Syndrome; Breast Neoplasms; Diabetes, Gestational

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Infections; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pregnancy Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kerri-Anne Mullen, PhD

  UOHI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-site, two-group, matched-cohort Vanguard study will be completed to test feasibility outcomes to inform a large, multi-site, two-group, longitudinal matched-cohort study.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 30, 2022
• Study Start: April 25, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)