[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06557707":3,"trial-entities:NCT06557707":105,"trial-summary:NCT06557707":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":44,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":79,"locations":82,"central_contacts":97,"overall_officials":100,"references":103,"see_also_links":104},"NCT06557707","HM20021768","Cardiovascular Health & Early Stress","RECRUITING","2028-12","2025-08","2025-09-04","2022-01-20","Virginia Commonwealth University","OTHER",true,"Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.\n\nACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.","Current knowledge supports that ACEs trigger emotional stress, anxiety, fear, and discomfort in the individual. Acute and intense mental stress leads to structural changes in the amygdala, prolonged activation of the hypothalamic-pituitary-adrenal axis, and hyperactivation of the sympathetic nervous system. Then, the body secretes hormones to activate the cardiovascular system to cope with stress with a rapid increase in arterial pressure and heart rate. If the trauma is severe and\u002For repeated, the resting state for heart rate and blood pressure are readjusted, resulting in these children living in a heightened physiological state of arousal, including higher heart and respiration rates. This status leads to endothelial dysfunction and atherothrombotic activation that can contribute to premature cardiovascular dysfunctions. Notably, there is evidence of a cumulative effect, or dose-response relationship, between the number of reported ACEs and the prevalence of health risk behaviors and chronic diseases. Thus, despite the prevalence of ACEs and the impact on health and society, the mechanisms underlying these dysfunctions are still poorly understood. The present study aims to understand the impact of different types of ACEs on cardiovascular health.",[18],"Stress",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},120,"ESTIMATED",[27],{"type":13,"name":28,"description":29,"armGroupLabels":30},"Childhood stress","Based on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed.",[31,32],"Children ACE (ages 9-17 years old)","Young individuals ACE (ages 18-30 years old)",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Vascular function","This test examines how the blood vessels respond to different challenges and expand. It is used to characterize the cardiovascular health of the subject's blood vessels. Different events and substances will be used (under an IND) to test how the blood vessels react. The test is completed using Laser Doppler Speckle Contrast. We will measure how much the blood vessels dilate. Greater dilation, better vascular function.","Baseline",{"measure":39,"description":40,"timeFrame":37},"Cardiac Function","An evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels.",{"measure":42,"description":43,"timeFrame":37},"Cardiac MRI (CMR)","Cardiac MRI will be completed to monitor early signs of poor functionality.",[45,48,51,54,56,58,61],{"measure":46,"description":47,"timeFrame":37},"Spirometry","Subjects will undergo a lung function test to measure how well their lungs work. The volume of air moving in and out of the lungs will be assessed. FEV1 will be evaluated. FEV1 is the amount of air a person can exhale in the first second after inhaling as deeply as possible.",{"measure":49,"description":50,"timeFrame":37},"Lung Diffusing Capacity","Subjects will undergo a lung function test to measure how well their air is diffused from their lungs. DLCO will be evaluated. DLCO stands for diffusing capacity of the lungs for carbon monoxide, and it's a pulmonary function test that measures how well oxygen moves from the lungs into the bloodstream.",{"measure":52,"description":53,"timeFrame":37},"Complete blood count","Blood analysis",{"measure":55,"description":53,"timeFrame":37},"HbA1c",{"measure":57,"description":53,"timeFrame":37},"C-Reactive protein",{"measure":59,"description":60,"timeFrame":37},"Questionnaires","Lifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk.",{"measure":62,"description":63,"timeFrame":37},"Arterial Stiffness","A non-invasive assessment will be used to measure how fast the participant's blood travels, which is a measure of how stiff their arteries are.","ALL","9 Years","30 Years",{"inclusion":68,"exclusion":73,"raw_text":78},[69,70,71,72],"Men and pre-menopausal women","18-30 years old","males and females","9-17 years old",[74,75,76,77,74,75,76,77],"Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases","Evidence of pregnancy or currently nursing.","Having a history of chronic pain","Having a history of rheumatoid arthritis","Inclusion Criteria:\n\nCohort 1\n\n* Men and pre-menopausal women\n* 18-30 years old\n\nCohort 2\n\n* males and females\n* 9-17 years old\n\nExclusion Criteria:\n\nCohort 1\n\n* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases\n* Evidence of pregnancy or currently nursing.\n* Having a history of chronic pain\n* Having a history of rheumatoid arthritis\n\nCohort 2\n\n* Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases\n* Evidence of pregnancy or currently nursing.\n* Having a history of chronic pain\n* Having a history of rheumatoid arthritis",[80,81],"CHILD","ADULT",[83],{"facility":12,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Richmond","Virginia","23298","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Paula Rodriguez Miguelez","CONTACT","804-396-4498","prodriguezmig@vcu.edu",{"lat":95,"lon":96},37.55376,-77.46026,[98],{"name":90,"role":91,"phone":99,"email":93},"(804) 396-4498",[101],{"name":90,"affiliation":12,"role":102},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[18],[],{"nct_id":4,"found":14,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study planning to enroll 120 participants. Participants will be divided into groups based on their childhood stress experiences.","completed","Observational Study on Childhood Stress and Cardiovascular Health","This observational study, called \"Cardiovascular Health & Early Stress,\" is looking at how childhood stress (also known as adverse childhood experiences or ACEs) might affect your heart and blood vessels. Researchers want to understand why experiencing difficult events as a child can lead to heart problems later in life. They will divide participants into groups based on whether they experienced adversity during childhood. The study will measure your vascular function (how well your blood vessels work) and cardiac function (how well your heart works), as well as take a cardiac MRI (a detailed picture of your heart) at the beginning of the study. This study is open to males and females aged 9 to 30 years old. The current recruitment status is unclear.","Vascular function, cardiac function, and cardiac MRI will be measured at Baseline (the start of the study).",123,"Not specified in the trial record.","Not stated in the trial record.",[28],"v2"]