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Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study (HER-CROWN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05632601
Recruitment Status : Recruiting
First Posted : November 30, 2022
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diagnostic Test: PET scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Actual Study Start Date : April 26, 2023
Estimated Primary Completion Date : May 24, 2024
Estimated Study Completion Date : May 24, 2024

Arm Intervention/treatment
Experimental: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group
  • Blood sample
  • Questionnaires
  • Arterial stiffness assessment
  • Transthoracic Echocardiogram
  • Coronary Computed Tomography Angiography (CTA)
  • Cardiac Positron Emission Tomography (PET)
Diagnostic Test: PET scan
PET scan

No Intervention: Sex-Specific Risk factor group and Age-Matched Control Group
  • Blood sample
  • Questionnaires
  • Arterial stiffness assessment



Primary Outcome Measures :
  1. Demographics questionnaire [ Time Frame: 18 months ]
    Demographics and socioeconomic information

  2. Medical History Questionnaire [ Time Frame: 18 months ]
    Past, present medical history, medication, and women's health related information

  3. General Anxiety Disorder-7 (GAD-7) [ Time Frame: 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


  4. Patient Health Questionnaire (PHQ)-9 [ Time Frame: 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


  5. Perceived Stress Scale (PSS) [ Time Frame: 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.

  6. The Index of Spouse Abuse (ISA) [ Time Frame: 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.

  7. Childhood Trauma Questionnaire (CTQ) [ Time Frame: 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.

  8. PTSD Checklist-5 (PCL-5) [ Time Frame: 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

  9. SF-12 [ Time Frame: 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).

  10. Substance use questionnaire [ Time Frame: 18 months ]
    Nicotine, alcohol, cannabis use measure questionnaire. No score.

  11. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 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.

  12. The Newest Vital Sign (NVS) [ Time Frame: 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.

  13. Arterial tonometry [ Time Frame: 18 months ]
    Arterial stiffness and arterial age

  14. Coronary CTA [ Time Frame: 18 months ]
    Coronary artery calcium, plaque presence and plaque characteristics

  15. Cardiac PET [ Time Frame: 18 months ]
    Coronary perfusion and microvascular function

  16. Transthoracic echocardiography [ Time Frame: 18 months ]
    Cardiac structure and function

  17. Blood work [ Time Frame: 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

  18. Satisfaction Questionnaire [ Time Frame: 18 months ]
    participant satisfaction and acceptability questionnaire. No score.



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female sex
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05632601


Contacts
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Contact: Kerri-Anne Mullen, PhD 6136967000 kmullen@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Kerri-Anne Mullen, PhD    6136967000    kmullen@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Kerri-Anne Mullen, PhD UOHI
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05632601    
Other Study ID Numbers: 20220586-01H
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
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
Additional relevant MeSH terms:
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Cardiovascular Diseases