NCT07849127Not yet recruiting
wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Women's Heart Austria
- Diseases
- Coronary artery disease
- NCT number
- NCT07849127
What you commit to
- Study type: Interventional
- Planned participants: 800
- From 1 Jan 2027 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known manifest atherosclerotic cardiovascular disease (prior myocardial infarction, coronary revascularisation, stroke)
Other illness
- Known contrast agent allergy with anaphylactic reaction
Lab values
- eGFR \< 30 ml/min/1.73 m² (KDIGO G4-G5)
Age
- Advanced oncological disease with life expectancy \< 3 years
Other
- Pregnancy at the time of baseline visit
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 40 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anna Rab Coordinator of this site? Confirm its status | Klagenfurt | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.