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Testing a heart risk score made for women aged 40 to 65 in Austria

Tests a new heart risk score in 800 women, plus a prevention programme.

Plain-language title generated from the registry record
Registry title: wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65

Key facts

Where
Klagenfurt, AustriaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 65 years old?

Source: NCT07849127, who can take part

Where in Austria

  • Anna RabKlagenfurt, AustriaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Women's Heart Austria
Trial code
NCT07849127
Record updated
30 September 2026
Original description
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.Read full original descriptionShow less

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

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).

Inclusion: Women aged 40-65 years; Pre-, peri-, or postmenopausal (including women with premature ovarian insufficiency and early menopause); Ability to provide written informed consent after thorough information; Extended inclusion of women with type 2 diabetes, pre-diabetes, and familial hypercholesterolaemia.

Exclusion: Known manifest atherosclerotic cardiovascular disease (prior myocardial infarction, coronary revascularisation, stroke); Known contrast agent allergy with anaphylactic reaction; eGFR < 30 ml/min/1.73 m² (KDIGO G4-G5); Advanced oncological disease with life expectancy < 3 years; Pregnancy at the time of baseline visit; Inability to provide informed consent.

ClinicalTrials.gov NCT07849127