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wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65
Sponsor: Women's Heart Austria
Summary
The wCAR-Austria Study is a multicentre, prospective, interventional study evaluating a novel women-specific cardiovascular risk score (wCAR) in 800 women aged 40-65 years across Austria. The wCAR score integrates conventional and women-specific cardiovascular risk factors - including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency, autoimmune disease, and menopause stage - into a three-axis, multiplicatively modular architecture. The study consists of two phases: A randomised, controlled interventional substudy (wCAR-CARE, PROBE design) allocates all participants with wCAR ≥ 11 points 1:1 to a structured precision-prevention arm (arm A, including tailored lifestyle intervention, structured statin evaluation, and menopausal hormone therapy counselling within the "window of opportunity") versus guideline-directed standard of care (arm B) for 24 months. Co-primary endpoints of Phase A are the area under the receiver-operating-characteristic curve (AUC) of the wCAR score for any coronary plaque (including non-calcified soft plaque on CCTA) in the intermediate stratum (E1a, n=100) and in the combined intermediate + high strata (E1b, n=200), analysed under a Bonferroni-Holm closed-testing procedure. The co-primary endpoint of wCAR-CARE is a composite risk-factor endpoint at month 24. The primary Phase B endpoint is time to first MACE. Secondary endpoints include reclassification improvement of wCAR versus SCORE2 and PREVENT, convergence validation against age-adjusted NT-proBNP percentiles, and convergence validation against high-sensitivity troponin-T using sex-specific thresholds per the Fifth Universal Definition of Myocardial Infarction (Mills et al., 2026).
Official title: Women's Cardiovascular Risk Score (wCAR) - Austria: A Multicentre Prospective Validation Study Using Photon-Counting Coronary CT Angiography, With the Randomised Interventional Substudy wCAR-CARE
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2027-01-01
Completion Date
2034-03-31
Last Updated
2026-09-30
Healthy Volunteers
Yes
Interventions
Arm 1: wCAR-CARE - Precision Prevention (Arm A)
• Description: Structured, phenotype-adapted precision prevention including tailored lifestyle intervention (defined behaviour targets: 7,000 steps/day on ≥ 5 days/week, ≥ 2 structured strength-training sessions/week, ≥ 30 vegetable portions/week, added sugar \< 25 g/day, alcohol \< 100 g/week, 7-9 hours of sleep, non-smoking), structured statin evaluation per ESC 2021 guidelines, and menopausal hormone therapy counselling per EMAS 2021 / NAMS 2022 within the "window of opportunity" (\< 10 years post-menopause). Follow-up contacts at M0, M1, M3, M6, M12, M18, M24.
Guideline-directed standard of care
Guideline-directed cardiovascular prevention care delivered by the participant's regular treating physicians without structured additional intervention. Participants continue their usual care pathway as clinically indicated by their treating physician, without protocol-mandated lifestyle coaching, structured statin evaluation, or menopausal hormone therapy counselling. Study-related follow-up contacts occur at Month 0, 3, 6, 12, 18, and 24 for structured ascertainment of the co-primary composite risk-factor endpoint (E2) and its components, without influencing clinical management decisions.
Locations (1)
Anna Rab
Klagenfurt, Austria