protocolSection identificationModule nctId: NCT06345573, orgStudyIdInfo id: BASEC 2020-02922, briefTitle: Heart-brain-axis and Psychosocial Stress, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-10-11, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease., conditionsModule conditions: Mental Stress, conditions: Myocardial Ischemia, conditions: Sex Role, conditions: Gender, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Mental stress, outcomesModule primaryOutcomes measure: Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV), primaryOutcomes measure: Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq), primaryOutcomes measure: Myocardial flow reserve (MFR, no unit), secondaryOutcomes measure: Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV), secondaryOutcomes measure: Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq), secondaryOutcomes measure: Myocardial blood flow (MBF) at rest (mL/g/min), secondaryOutcomes measure: Myocardial blood flow (MBF) at stress (mL/g/min), secondaryOutcomes measure: Heart-rate response (HRR, no unit), secondaryOutcomes measure: Salivary cortisol (mol/L), secondaryOutcomes measure: Noradrenaline (mL/min), secondaryOutcomes measure: Adrenaline (mL/min), secondaryOutcomes measure: Dopamine (mL/min), secondaryOutcomes measure: Spleen metabolic activity (SUV), secondaryOutcomes measure: Bone marrow metabolic activity (SUV), secondaryOutcomes measure: Aorta metabolic activity (SUV), secondaryOutcomes measure: Left ventricular ejection fraction (LVEF, %), secondaryOutcomes measure: C-reactive protein (CRP, mg/L), secondaryOutcomes measure: Interleukin-2 (IL-2, pg/mL), secondaryOutcomes measure: Interleukin-4 (IL-4, pg/mL), secondaryOutcomes measure: Interleukin-6 (IL-6, pg/mL), secondaryOutcomes measure: Interleukin-8 (IL-8, pg/mL), secondaryOutcomes measure: Interleukin-10 (IL-10, pg/mL), secondaryOutcomes measure: Tumor necrosis factor (TNF, pg/mL), secondaryOutcomes measure: Matrix metalloproteinase-9 (MMP9, pg/mL), secondaryOutcomes measure: Monocyte Chemoattractant Protein-1 (MCP1, pg/mL), secondaryOutcomes measure: Vascular Cell Adhesion Molecule (VCAM), secondaryOutcomes measure: Gender score questionnaire, otherOutcomes measure: Rate-Pressure-Product (RPP, in beats per minute x mmHg), otherOutcomes measure: vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV), otherOutcomes measure: Nail cortisol value (pg/mg), otherOutcomes measure: General Anxiety Disorder (GAD-7) Questionnaire, otherOutcomes measure: Patient Health Questionnaire (PHQ-8), otherOutcomes measure: Shortened Maastricht Exhaustion Questionnaire, otherOutcomes measure: Type D Personality (DS14) questionnaire, otherOutcomes measure: Wagnild & Young Score resilience questionnaire, otherOutcomes measure: Perceived Stress Scale (PSS-4) questionnaire, otherOutcomes measure: Jenkins Sleep Scale (JSS-4), otherOutcomes measure: Trier Inventory for Chronic Stress (TICS), otherOutcomes measure: Perceived stress, otherOutcomes measure: Left ventricular stroke volume (LVSV, mL), otherOutcomes measure: Left ventricular end-systolic volume (LVESV, mL), otherOutcomes measure: Left ventricular end-diastolic volume (LVEDV, mL), otherOutcomes measure: Estradiol levels (pmol/L), otherOutcomes measure: Progesterone levels (nmol/L), otherOutcomes measure: Sex Hormone Binding Globulin (SHBG) levels (nmol/L), otherOutcomes measure: Total testosterone levels (nmol/L), otherOutcomes measure: Free testosterone levels (pmol/L), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, city: Zürich, zip: 8091, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False