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

Condition(s) studied

Investigational drug(s) / intervention(s)

PET scan: PET scan

Study 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.

Eligibility

Primary outcome measure(s)

• 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 PSS 10 item scale.
• The Index of Spouse Abuse (ISA) — 18 months
  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.
• Childhood Trauma Questionnaire (CTQ) — 18 months
  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.
• PTSD Checklist-5 (PCL-5) — 18 months
  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
• SF-12 — 18 months
  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).
• Substance use questionnaire — 18 months
  Nicotine, alcohol, cannabis use measure questionnaire. No score.
• International Physical Activity Questionnaire (IPAQ) — 18 months
  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.
• The Newest Vital Sign (NVS) — 18 months
  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.
• Arterial tonometry — 18 months
  Arterial stiffness and arterial age
• Coronary CTA — 18 months
  Coronary artery calcium, plaque presence and plaque characteristics
• Cardiac PET — 18 months
  Coronary perfusion and microvascular function
• Transthoracic echocardiography — 18 months
  Cardiac structure and function
• Blood work — 18 months
  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
• Satisfaction Questionnaire — 18 months
  participant satisfaction and acceptability questionnaire. No score.

Trial sites (1)

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