[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07260032":3,"trial-entities:NCT07260032":103,"trial-summary:NCT07260032":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":80,"locations":83,"central_contacts":98,"overall_officials":100,"references":101,"see_also_links":102},"NCT07260032","2024P003032","Determining the Benefits of Exercise on Cardiovascular Risk in PTSD","Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD","RECRUITING","2027-01-31","2025-11","2025-12-02","2025-02-01","Massachusetts General Hospital","OTHER",false,"The purpose of this study is to use a non-invasive imaging technique called positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) to investigate the effects of exercise on brain activity and arterial (blood vessel) inflammation in people with PTSD symptoms and evidence of or elevated risk for artery disease.",null,[19,20,21],"PTSD","Cardiovascular Disease","Cardiovascular Disease Risk Factors",[],"INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},10,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Exercise","The exercise program will consist of specifically designed activities to place a gradually increasing workload on the cardiovascular system.",[33],[37,41,44,47,50],{"measure":38,"description":39,"timeFrame":40},"Heart rate","10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)","Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)",{"measure":42,"description":43,"timeFrame":40},"Blood pressure","Systolic and diastolic blood pressure",{"measure":45,"description":46,"timeFrame":40},"Heart rate variability","10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)",{"measure":48,"description":49,"timeFrame":40},"Arterial inflammation","Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites",{"measure":51,"description":52,"timeFrame":40},"Bone marrow inflammation","Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography",[],"ALL","18 Years","65 Years",{"inclusion":58,"exclusion":64,"raw_text":79},[59,60,61,62,63],"Age 18-65 years","Trauma exposure","PTSD symptoms","Subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \\>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking)","Ability to understand and sign informed consent",[65,66,67,68,69,70,71,72,73,74,75,76,77,78],"History of stroke, brain surgery, or seizure","Use of certain CVD medications (e.g., beta-blockers, high-intensity statins \\[e.g., rosuvastatin 20\u002F40 mg and atorvastatin 40\u002F80 mg\\], PCSK-9 inhibitors)","Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed)","Unstable blood pressure or cardiac arrhythmia","Currently in a supervised or graduated exercise program","Neurological or systemic inflammatory disease\u002Fcurrent systemic anti-inflammatory therapy","Moderate\u002Fsevere alcohol\u002Fsubstance use disorder","Current mania\u002Fpsychosis","Weight \\>300 lbs.","Claustrophobia","Pregnancy","Metal implants","Uncontrolled hyperglycemia (HgbA1c\\>7.5%)","Subjects who have had significant radiation exposure as part of research (\\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months","Inclusion Criteria:\n\n* Age 18-65 years\n* Trauma exposure\n* PTSD symptoms\n* Subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \\>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking)\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* History of stroke, brain surgery, or seizure\n* Use of certain CVD medications (e.g., beta-blockers, high-intensity statins \\[e.g., rosuvastatin 20\u002F40 mg and atorvastatin 40\u002F80 mg\\], PCSK-9 inhibitors)\n* Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed)\n* Unstable blood pressure or cardiac arrhythmia\n* Currently in a supervised or graduated exercise program\n* Neurological or systemic inflammatory disease\u002Fcurrent systemic anti-inflammatory therapy\n* Moderate\u002Fsevere alcohol\u002Fsubstance use disorder\n* Current mania\u002Fpsychosis\n* Weight \\>300 lbs.\n* Claustrophobia\n* Pregnancy\n* Metal implants\n* Uncontrolled hyperglycemia (HgbA1c\\>7.5%)\n* Subjects who have had significant radiation exposure as part of research (\\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":13,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":95},"Boston","Massachusetts","02114","United States",[90],{"name":91,"role":92,"phone":93,"email":94},"Antonia Seligowski, PhD","CONTACT","617-643-0954","aseligowski@mgh.harvard.edu",{"lat":96,"lon":97},42.35843,-71.05977,[99],{"name":91,"role":92,"phone":93,"email":94},[],[],[],{"nct_id":4,"conditions":104,"biomarkers":107},[105,106],"Atherosclerosis","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 10 participants. It will test the effects of an exercise program.","completed","Exercise for PTSD and Heart Disease Risk","This study is looking at how an exercise program might help people with symptoms of Post-Traumatic Stress Disorder (PTSD) who also have, or are at risk for, artery disease. Researchers will use special imaging (PET\u002FMRI) to see how exercise affects brain activity and inflammation in blood vessels. The study is open to adults aged 18-65 who have experienced trauma, have PTSD symptoms, and show signs of or are at increased risk for artery disease. Success will be measured by changes in heart rate, blood pressure, and heart rate variability after 12-16 weeks of exercise. The current status of this study is unclear, and it plans to enroll 10 participants.","Measurements will be taken at the beginning and again 12-16 weeks after the initial visit.",109,"You would participate in an exercise program. Your heart rate, blood pressure, and heart rate variability would be measured before and after 12-16 weeks of the program.","Not stated in the trial record.",[33],"v2"]