[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470115":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":28,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":28,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Emory University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Symptomatic women with no obstructive CAD who have CMD","EXPERIMENTAL","Symptomatic women with chest pain and no obstructive CAD who have an abnormal myocardial flow reserve (MFR \\\u003C 2.5)",[13],"Other: Study Procedures",{"label":15,"type":10,"description":16,"interventionNames":17},"Symptomatic women with chronic obstructive CAD (oCAD)","This group will serve as one comparison group since these women represent the prevailing paradigm of ischemia from obstructive stenosis while sharing common cardiovascular risk factors with the CMD group.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Asymptomatic control women with no prior history of CAD or angina","ACTIVE_COMPARATOR","Asymptomatic control women with no prior history of CAD or angina, who are age-matched to the CMD women; not on any cardiac medications, who will also have to pass a maximal Bruce protocol exercise treadmill test.",[13],[24],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Study Procedures","All participants will answer a series of questionnaires that address several factors such as patient medical history, family history, medication usage, health behaviors, psychological factors, etc. Questionnaires related to symptoms, psychological factors, depression, anxiety, and quality of life will be taken.\n\nAll participants will undergo 123I-MIBG SPECT imaging in the morning in a fasting state. Mental Stress Testing will be conducted in the Laboratory in the morning after fasting for at least 4 hours and withdrawal of all vasoactive medications, caffeine, and tobacco 24-48 hours before testing. Participants will also undergo 1-week of Home Monitoring using a single-use, noninvasive, water-resistant, 7-day ambulatory ECG monitoring, which offers the advantage of direct access to raw data that can be downloaded from the device after use.\n\nA 3-day food recall diary, cognitive assessments via the NIH Toolbox, and a Sleep diary during home monitoring will be collected.",[19,15,9],null,[30],{"name":31,"affiliation":5,"role":32},"Puja K Mehta","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Puja K Mehta, MD","CONTACT","404-712-0281","pkmehta@emory.edu",{"name":35,"role":36,"phone":28,"phoneExt":28,"email":28},[41,55,60,66],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":28},"Emory Hospital Midtown","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.38798,33.749,{"lat":53,"lon":52},{"facility":56,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":57,"geoPoint":59,"contacts":28},"Emory Saint Joseph's Hospital",{"type":50,"coordinates":58},[52,53],{"lat":53,"lon":52},{"facility":61,"status":43,"city":44,"state":45,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":65,"contacts":28},"Emory Clinic","30322",{"type":50,"coordinates":64},[52,53],{"lat":53,"lon":52},{"facility":67,"status":43,"city":44,"state":45,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":70,"contacts":28},"Emory Hospital",{"type":50,"coordinates":69},[52,53],{"lat":53,"lon":52},{"type":32,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Puja Mehta","Associate Professor",[75],{"name":76,"class":77},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100470115","mental-stress-reactivity-in-women-with-cmd-100470115",false,"NCT05401630","Mental Stress Reactivity in Women With CMD","Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction","CMD Group\n\nInclusion Criteria:\n\n* Symptomatic postmenopausal women with chest pain\n* age≥45 years old\n* willing to undergo cardiac MIBG scan\n* willing to undergo mental stress testing\n* competent to give informed consent\n\nExclusion Criteria:\n\n* Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)\n* Left ventricular systolic dysfunction (ejection fraction ≤ 50%)\n* Heart failure with a preserved ejection fraction\n* Significant anemia or blood dyscrasia\n* Severe uncontrolled hypertension \\>180\u002F100\n* Unable to lie flat for mental stress testing\n* Pre-menopausal\n* Pregnant\n* Pericarditis\u002Fmyocarditis\n* History of percutaneous coronary intervention\n* Coronary artery bypass grafting\n* Acute myocardial infarction\u002Facute coronary syndrome\u002Funstable angina within 1 month\n* Significant valvular disease, including aortic or mitral stenosis\n* Sinus node dysfunction\u002Fpacemaker, 2nd or 3rd-degree atrioventricular block\n* Severe lung, renal, liver, or psychiatric illness\n* Current neoplasm\n* History of substance abuse\n* Acute illness such as infection in the previous 4 weeks\n* Life-expectancy less than 2 years\n* Unable to safely withdraw medications for mental stress testing\n* Significant psychiatric illness that precludes safe participation in the study\n* Conditions that preclude accurate or safe testing and patient refusal\n* Unable to consent\n\nObstructive CAD (oCAD) Group\n\nInclusion Criteria:\n\n* Symptomatic postmenopausal women with chest pain who have obstructive CAD in at least one epicardial coronary artery\n* willing to undergo cardiac MIBG scan\n* willing to undergo mental stress testing\n* competent to give informed consent\n\nExclusion Criteria:\n\n* Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)\n* Left ventricular systolic dysfunction (ejection fraction ≤ 50%)\n* Heart failure with a preserved ejection fraction\n* Significant anemia or blood dyscrasia\n* Severe uncontrolled hypertension \\>180\u002F100\n* Unable to lie flat for mental stress testing\n* Pre-menopausal\n* Pregnant\n* Pericarditis\u002Fmyocarditis\n* History of percutaneous coronary intervention\n* Coronary artery bypass grafting\n* Acute myocardial infarction\u002Facute coronary syndrome\u002Funstable angina within 1 month\n* Significant valvular disease, including aortic or mitral stenosis\n* Sinus node dysfunction\u002Fpacemaker, 2nd or 3rd-degree atrioventricular block\n* Severe lung, renal, liver, or psychiatric illness\n* Current neoplasm\n* History of substance abuse\n* Acute illness such as infection in the previous 4 weeks\n* Life expectancy is less than 2 years\n* Unable to safely withdraw medications for mental stress testing\n* Significant psychiatric illness that precludes safe participation in the study\n* Conditions that preclude accurate or safe testing and patient refusal\n* Unable to consent\n\nAsymptomatic Control Group\n\nInclusion Criteria:\n\n* Asymptomatic postmenopausal women, age ≥ 45 years old\n* Healthy volunteer with no cardiac risk factors\n* No history or diagnosis of heart disease\n* Not on any cardiac medications\n* Normal maximal exercise treadmill stress testing (ETT)\n* Fully understanding and willing to undergo mental stress testing\n* Willing to sign the informed consent\n\nExclusion Criteria:\n\n* Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)\n* Left ventricular systolic dysfunction (ejection fraction ≤ 50%)\n* Heart failure with a preserved ejection fraction\n* Significant anemia or blood dyscrasia\n* Severe uncontrolled hypertension \\>180\u002F100\n* Unable to lie flat for mental stress testing\n* Pre-menopausal\n* Pregnant\n* Pericarditis\u002Fmyocarditis\n* History of percutaneous coronary intervention\n* Coronary artery bypass grafting\n* Acute myocardial infarction\u002Facute coronary syndrome\u002Funstable angina within 1 month\n* Significant valvular disease, including aortic or mitral stenosis\n* Sinus node dysfunction\u002Fpacemaker, 2nd or 3rd-degree atrioventricular block\n* Severe lung, renal, liver, or psychiatric illness\n* Current neoplasm\n* History of substance abuse\n* Acute illness such as infection in the previous 4 weeks\n* Life expectancy is less than 2 years\n* Unable to safely withdraw medications for mental stress testing\n* Significant psychiatric illness that precludes safe participation in the study\n* Orthopedic limitation that will prevent ETT\n* LDL \\>120 mg\u002FdL\n* Fasting blood glucose \\>95 mg\u002FdL\n* Hypertension, defined as resting BP \\>120\u002F80\n* Diabetes\n* Hyperlipidemia\n* Smoking\n* Conditions that preclude accurate or safe testing and patient refusal\n* Unable to consent","FEMALE","45 Years",{"count":88,"type":89},150,"ESTIMATED","INTERVENTIONAL",[92],"NA","Coronary Microvascular Dysfunction (CMD) occurs when there are problems in the small blood vessels\u002Farteries of the heart, resulting in persistent chest pain that affects women.\n\nThere are an estimated 3 million women in the US with CMD and about 100,000 new cases annually. This research will investigate whether the stress response physiology and autonomic function in response to mental stress are different in women with CMD compared to other groups. The autonomic nervous system (ANS) controls normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. This study will also examine how chronic and daily life mental stress affects the heart and blood vessels.\n\nParticipants from this study will be recruited mainly from Emory Healthcare-associated hospitals, the Emory Heart Disease Center for Prevention, and Emory Healthcare outpatient cardiology clinics. Participants will have physical exams, blood tests, stress tests, exercise tests, surveys, questionnaires, and images taken of their hearts and blood vessels. They will be asked to take home devices to monitor their autonomic function, sleep, and track their mood, stress level, and symptoms for one week. Data and specimens will be saved for future research.",[95],"Post-menopause",[97,98,99,100],"Microvascular","Sympathetic activity","Mental Stress","Angina","2026-01-27",{"date":103,"type":104},"2026-01-29","ACTUAL",{"date":106,"type":104},"2022-07-19",{"date":108,"type":89},"2026-12-31",{"name":5,"class":6},4]