Trial Title:
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
NCT ID:
NCT05632601
Condition:
Cardiovascular Diseases
Conditions: Official terms:
Cardiovascular Diseases
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PET scan
Description:
PET scan
Arm group label:
Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group
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.
Detailed description:
Cardiovascular diseases (CVD), including ischemic heart disease (IHD), peripheral
vascular disease (PVD), and stroke, remain the leading preventable cause of death among
Canadian women, resulting in over 34,000 deaths per year (age-standardized death rate:
25.1%). Nearly 40% of CVD-related deaths in women are due to IHD. Increased awareness
efforts and effective treatments have led to an overall decline in CVD mortality among
men and women in high income countries over the past few decades; however, alarmingly, an
increase in CVD mortality has been observed in women in the most recent 5 to 10 years in
Canada and the United States, and an upward trend in rates of AMI among younger women.
CVD in women remains understudied, under-diagnosed, and undertreated. Clinical guidelines
are largely based on studies of men. Several existing large longitudinal cohort studies
(e.g., the Nurses' Health Study, The Framingham Heart Study, the PURE study) have
included women; however, they have not focused recruitment specifically on high-risk
cohorts of women or on risk factors that are unique to women, more common in women, or
that disproportionately affect women; they have not used novel measures of subclinical
disease in women (e.g., coronary computed tomography angiography and cardiac Rb-positive
emission tomography); and most have not recruited representative samples of women in
terms of ethnicity or socioeconomic status. CVD risk calculators (e.g., Framingham, the
American College of Cardiology ASCVD) focus on traditional risk factors (e.g., tobacco
smoking, hypertension, diabetes), do not include sex-specific CVD risk factors or factors
that disproportionately affect women, and thus tend to underestimate risk in women.
Female-specific factors that have been associated with CVD risk include: premature or
late menarche, abnormal menses, premature or early menopause, gestational hypertensive
disorders, gestational diabetes, preterm delivery, pregnancy loss, hormonal contraceptive
use, and polycystic ovarian syndrome. Risk factors that are under-recognized or
disproportionately affect women include: rheumatologic inflammatory disorders (RIDs),
depression, anxiety, chronic stress, abuse and intimate partner violence, and health
literacy. In addition, a more feminine gender role has been shown to be associated with
higher risk of reinfarction after premature acute coronary syndrome, but no additional
research on gender roles and future cardiovascular risk is available. Importantly, novel
cardiovascular risk markers such as measures of arterial stiffness and aging, among
others, have not been prospectively evaluated in a female population. As such, additional
longitudinal research is needed to understand the natural history of CVD and the impact
of these 'non-conventional' risk factors in women.
A recent article published in the Lancet by a multi-national group of women's heart
health experts reviewed existing evidence, identified knowledge gaps, and provided
specific recommendations related to CVD research, prevention, treatment, and access to
care for women. The HER CROWN longitudinal cohort study will respond to three important
gaps identified in this review, specifically: 1) describe the pathophysiology and natural
history of cardiovascular disease in women; 2) determine the impact of sex-specific,
psychosocial, and socioeconomic risk factors on CVD in women; and, 3) improve CVD risk
prediction/ risk stratification models for women. The Vanguard phase of the study will
evaluate the feasibility of the full study being planned.
The full HER CROWN will be a prospective matched-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. The study
will be cross-disciplinary, including investigators who specialize in the treatment of
cardiovascular disease in women, epidemiology and administrative data, cardiovascular
imaging, biomarker research, physical activity, nutrition, nicotine addiction, and mental
health who will each inform outcomes and sub-studies.
Criteria for eligibility:
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)
Gender:
Female
Gender based:
Yes
Gender description:
Female sex
Minimum age:
25 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Ottawa Heart Institute
Address:
City:
Ottawa
Zip:
K1Y 4W7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Kerri-Anne Mullen, PhD
Phone:
6136967000
Email:
kmullen@ottawaheart.ca
Start date:
April 25, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Ottawa Heart Institute Research Corporation
Agency class:
Other
Source:
Ottawa Heart Institute Research Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05632601
