Cardiovascular Diseases Clinical Trial
— HER-CROWNOfficial title:
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | May 24, 2024 |
Est. primary completion date | May 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 55 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demographics questionnaire | Demographics and socioeconomic information | 18 months | |
Primary | Medical History Questionnaire | Past, present medical history, medication, and women's health related information | 18 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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: item recoding for the four items that require recoding; computing scale scores by summing across items in the same scale (raw scale scores); and, transforming raw scale scores to a 0-100 scale (transformed scale scores). |
18 months | |
Primary | Substance use questionnaire | Nicotine, alcohol, cannabis use measure questionnaire. No score. | 18 months | |
Primary | 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 | |
Primary | 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 | |
Primary | Arterial tonometry | Arterial stiffness and arterial age | 18 months | |
Primary | Coronary CTA | Coronary artery calcium, plaque presence and plaque characteristics | 18 months | |
Primary | Cardiac PET | Coronary perfusion and microvascular function | 18 months | |
Primary | Transthoracic echocardiography | Cardiac structure and function | 18 months | |
Primary | Blood work | CBC, electrolytes, creatinine, fasting lipids, fasting glucose, HbA1c, hs-troponin, NT-proBNP, Lipoprotein (a), LH, FSH, estradiol, progesterone, additional sample for biobanking ßhCG test for subsamples participating in PET and Coronary CTA | 18 months | |
Primary | Satisfaction Questionnaire | participant satisfaction and acceptability questionnaire. No score. | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|