[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Women's Heart Austria\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100658283","wcar-austria-a-women-specific-score-to-assess-cardiovascular-risk-in-women-aged-40-to-65-100658283",false,"NCT07849127","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","wCAR-Austria","Inclusion Criteria:\n\n* Women aged 40-65 years\n* Pre-, peri-, or postmenopausal (including women with premature ovarian insufficiency and early menopause)\n* Ability to provide written informed consent after thorough information\n* Extended inclusion of women with type 2 diabetes, pre-diabetes, and familial hypercholesterolaemia\n\nExclusion Criteria:\n\n* Known manifest atherosclerotic cardiovascular disease (prior myocardial infarction, coronary revascularisation, stroke)\n* Pregnancy at the time of baseline visit\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m² (KDIGO G4-G5)\n* Advanced oncological disease with life expectancy \\\u003C 3 years\n* Known contrast agent allergy with anaphylactic reaction\n* Inability to provide informed consent",true,"FEMALE","40 Years","65 Years",{"count":22,"type":23},800,"ESTIMATED","INTERVENTIONAL",[26],"NA","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.\n\nThe study consists of two phases:\n\nA 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.\n\nCo-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.\n\nSecondary 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).",[29,30,31],"Cardiovascular Diseases (CVD)","Coronary Artery Disease","Atheroscleroses",[33,34,35,36,37,38,39,40],"coronary artery calcium; NT-proBNP; menopause; sex-specific risk stratification; women's cardiovascular health; midlife","coronary artery calium","NT-proBNP","Menopause","sex-specific risk stratification","coronary artery calcium","women's cardiovascular health","midlife","NOT_YET_RECRUITING","2026-09-23",{"date":44,"type":45},"2026-09-30","ACTUAL",{"date":47,"type":23},"2027-01-01",{"date":49,"type":23},"2034-03-31",{"name":51,"class":52},"Women's Heart Austria","OTHER",""]