[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658283":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":34,"studyPopulation":25,"armGroups":35,"interventions":51,"overallOfficials":25,"centralContacts":61,"locations":69,"responsibleParty":85,"collaborators":25,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":119,"whyStopped":25,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Women's Heart Austria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Area Under the ROC Curve (AUC) of the wCAR Score for Detecting Any Coronary Plaque on Photon-Counting CCTA in Women With Intermediate wCAR Risk (6-10 Points)","Discriminative performance of the women's cardiovascular risk (wCAR) total score for the presence of any coronary plaque (calcified, mixed or non-calcified) on photon-counting coronary computed tomography angiography (CCTA), with central core-lab image evaluation blinded to the wCAR score. Analysis population: study-mandated CCTA participants randomly sampled from the intermediate wCAR stratum (6-10 points, n=100). Reported as AUC with 95% confidence interval (ROC analysis, DeLong method; bootstrap confidence intervals). Co-primary with E1b; multiplicity controlled by Bonferroni-Holm closed testing. Protocol endpoint E1a.","At baseline (Phase A cross-sectional assessment)",{"measure":14,"description":15,"timeFrame":16},"Time to First Major Adverse Cardiovascular Event (MACE: Cardiovascular Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Coronary Revascularisation) by wCAR Risk Category","Prognostic value of the wCAR score for MACE in the total cohort (n=800). MACE is defined as the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation, adjudicated by an independent endpoint committee blinded to participant identity using pseudonymised clinical records. Reported as hazard ratio with 95% CI for wCAR categories R3\u002FR4 versus R1\u002FR2 (Cox proportional hazards regression) and Harrell's C-statistic; Kaplan-Meier estimates by wCAR risk category. Protocol endpoint Phase B.","Up to 5 years after baseline (minimum follow-up 3 years)",{"measure":18,"description":19,"timeFrame":20},"Percentage of Participants Achieving the Composite Risk-Factor Endpoint at Month 24 (wCAR Class Improvement or Reduction in LDL-C, Systolic Blood Pressure, TyG Index or HbA1c)","Binary composite endpoint, achieved if at least one of the following criteria is met at month 24 compared with baseline: (a) improvement by at least one wCAR risk class (e.g., very high to high); (b) LDL-C reduction of at least 15%; (c) systolic blood pressure reduction of at least 10 mmHg; (d) TyG index reduction of at least 10%; (e) HbA1c reduction of at least 0.3 percentage points (participants with prediabetes or type 2 diabetes only). Population: participants with wCAR score of 11 points or higher randomised 1:1 to Arm A (wCAR-guided precision prevention) or Arm B (guideline-based standard care). Endpoint assessment blinded to arm allocation (PROBE design). Reported as number and percentage of participants achieving the endpoint per arm; primary analysis by intention-to-treat using logistic regression adjusted for centre and wCAR stratum (risk difference and odds ratio with 95% CI). Protocol endpoint E2 (wCAR-CARE substudy).","24 months after randomisation",{"measure":22,"description":23,"timeFrame":24},"Area Under the ROC Curve (AUC) of the wCAR Score for Detecting Any Coronary Plaque on Photon-Counting CCTA in Women With Intermediate or High wCAR Risk (6-15 Points)","Discriminative performance of the women's cardiovascular risk (wCAR) total score for the presence of any coronary plaque (calcified, mixed or non-calcified) on photon-counting coronary computed tomography angiography (CCTA), with central core-lab image evaluation blinded to the wCAR score. Analysis population: study-mandated CCTA participants randomly sampled from the intermediate (6-10 points, n=100) and high (11-15 points, n=100) wCAR strata (combined n=200). Reported as AUC with 95% confidence interval (ROC analysis, DeLong method; bootstrap confidence intervals). Co-primary with E1a; multiplicity controlled by Bonferroni-Holm closed testing. Protocol endpoint E1b.","At baseline (Phase A cross-sectional CCTA assessment)",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":31,"maskingDescription":25,"whoMasked":32},"SINGLE",[33],"OUTCOMES_ASSESSOR","Background. Cardiovascular disease is the leading cause of death in women in Austria and worldwide, yet women are systematically under-recognised in cardiovascular risk assessment. Established risk scores such as SCORE2 and PREVENT do not adequately incorporate women-specific risk factors including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency (POI), autoimmune disease, elevated lipoprotein(a), or menopausal status. The women-specific cardiovascular risk score wCAR was developed to address this gap and integrates conventional and women-specific risk factors in a three-axis, multiplicatively modular architecture. In a monocentric pilot study of 107 women, wCAR showed an AUC of 0.66 for coronary artery calcium (CAC \\> 0) versus 0.52 for PREVENT-ASCVD.\n\nDesign. Multicentre, prospective, interventional two-phase study enrolling 800 women aged 40-65 across six Austrian centres.\n\nPhase A - cross-sectional validation (12 months). All participants undergo clinical examination (blood pressure, height, weight, waist circumference - WHtR as primary adiposity indicator, BMI as secondary covariate), extended laboratory testing (lipid profile including Lp\\[a\\], HbA1c, fasting glucose for TyG-Index, creatinine\u002FeGFR, hs-CRP, NT-proBNP with age- and sex-adjusted percentile referencing, hs-troponin-T with sex-specific thresholds per Fifth UDMI 2026, uric acid), validated questionnaires (Menopause Rating Scale, WHO-5, PHQ-9, Food Frequency Questionnaire), and calculation of wCAR, SCORE2, and PREVENT scores.\n\nCoronary photon-counting CT angiography (CCTA) is performed in a stratified randomised subset of 250 participants:\n\nThis stratified sampling minimises cumulative radiation exposure while providing sufficient statistical power for the primary endpoints. Photon-counting CCTA delivers 1-3 mSv effective dose, comparable to natural annual background radiation. All images are centrally analysed by a core laboratory using CE-marked Siemens Healthineers software.\n\nPhase B - prospective follow-up (3-5 years). Annual structured contact with all 800 participants; MACE ascertainment and adjudication by an independent endpoint committee blinded to treatment allocation.\n\nwCAR-CARE interventional substudy. All Phase A participants with wCAR ≥ 11 points are randomised 1:1 to arm A (structured precision-prevention intervention including tailored lifestyle intervention with defined behaviour targets - 7,000 steps per day on at least 5 days per week, at least two structured strength-training sessions per week, at least 30 vegetable portions per week, added sugar less than 25 g per day, alcohol less than 100 g per week, 7-9 hours of sleep, non-smoking - structured statin evaluation, and MHT counselling within the \"window of opportunity\") versus arm B (guideline-directed standard of care). Intervention duration: 24 months. Co-primary endpoint E2: composite risk-factor endpoint at month 24 (achievement of at least one of: ≥ 1 wCAR class improvement, LDL-C reduction ≥ 15%, systolic blood pressure reduction ≥ 10 mmHg, TyG-Index reduction ≥ 10%, HbA1c reduction ≥ 0.3 percentage points in participants with pre-diabetes or T2DM).\n\nEDC × Sugar substudy. In a stratified subsample of 200 participants, an exploratory analysis examines the association between endocrine-disrupting chemical exposure (urinary phthalate and bisphenol metabolites, optionally serum PFAS) and sugar consumption with coronary plaque status.\n\nStatistical analysis. ROC analyses using DeLong's method for AUC comparisons; NRI and IDI with bootstrap confidence intervals; Cox proportional hazards regression; mixed models for longitudinal data. Convergence validation of wCAR against age-adjusted NT-proBNP percentiles and against sex-specific hs-troponin-T (Fifth UDMI 2026) across the entire cohort (n=800).\n\nEthics. Approved by the Ethics Committee of Carinthia (M2026-15, valid until 27 August 2027). Local ethics approvals for additional participating centres are pending.\n\nFunding. Investigator-initiated trial funded through the Association's own resources and in-kind contributions from Siemens Healthcare Diagnostics GmbH (imaging equipment, analysis software, participant insurance). No public or private project funding in the form of monetary grants.",[36,42,45],{"label":37,"type":38,"description":39,"interventionNames":40},"Structured, phenotype-adapted precision prevention including tailored lifestyle intervention (define","EXPERIMENTAL","• Intervention: Behavioural \u002F Drug",[41],"Behavioral: Arm 1: wCAR-CARE - Precision Prevention (Arm A)",{"label":43,"type":44,"description":25,"interventionNames":25},"Phase A cross-sectional characterisation without study-related intervention; participants with wCAR","NO_INTERVENTION",{"label":46,"type":47,"description":48,"interventionNames":49},"wCAR-CARE - Guideline-Directed Standard of Care (Arm B)","ACTIVE_COMPARATOR","* Description: Guideline-directed cardiovascular prevention care delivered by the participant's regular treating physicians without structured additional intervention. Study-related follow-up contacts at M0, M3, M6, M12, M18, M24 for structured E2 component ascertainment.\n* Intervention: Standard of Care",[50],"Behavioral: Guideline-directed standard of care",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":25},"BEHAVIORAL","Arm 1: wCAR-CARE - Precision Prevention (Arm A)","• Description: Structured, phenotype-adapted precision prevention including tailored lifestyle intervention (defined behaviour targets: 7,000 steps\u002Fday on ≥ 5 days\u002Fweek, ≥ 2 structured strength-training sessions\u002Fweek, ≥ 30 vegetable portions\u002Fweek, added sugar \\\u003C 25 g\u002Fday, alcohol \\\u003C 100 g\u002Fweek, 7-9 hours of sleep, non-smoking), structured statin evaluation per ESC 2021 guidelines, and menopausal hormone therapy counselling per EMAS 2021 \u002F NAMS 2022 within the \"window of opportunity\" (\\\u003C 10 years post-menopause). Follow-up contacts at M0, M1, M3, M6, M12, M18, M24.",[37],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"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.",[46],[62,67],{"name":63,"role":64,"phone":65,"phoneExt":25,"email":66},"Anna Rab, MD","CONTACT","+43 676 3610516","anna.rab@icloud.com",{"name":68,"role":64,"phone":25,"phoneExt":25,"email":25},"Steringer",[70],{"facility":71,"status":25,"city":72,"state":25,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Anna Rab","Klagenfurt","9020","Austria","AT",{"type":77,"coordinates":78},"Point",[79,80],14.30528,46.62472,{"lat":80,"lon":79},[83],{"name":63,"role":64,"phone":84,"phoneExt":25,"email":66},"+43 6767216660",{"type":86,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":100,"type":101},800,"ESTIMATED","INTERVENTIONAL",[104],"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).",[107,108,109],"Cardiovascular Diseases (CVD)","Coronary Artery Disease","Atheroscleroses",[111,112,113,114,115,116,117,118],"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":122,"type":123},"2026-09-30","ACTUAL",{"date":125,"type":101},"2027-01-01",{"date":127,"type":101},"2034-03-31",{"name":5,"class":6},1]