NCT05401630Toboroz
Mental Stress Reactivity in Women With CMD
Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
Coronary Microvascular Dysfunction (CMD) occurs when there are problems in the small blood vessels/arteries of the heart, resulting in persistent chest pain that affects women. There 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. Participants 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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tervezett)
- Első benyújtás
- 2022. máj. 10.
- Kezdés
- 2022. júl. 19.
- Elsődleges befejezés
- 2028. dec.
- Fő szponzor
- Emory University
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT05401630
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 150
- 2022. júl. 19. és az elsődleges befejezés (2028. dec.) között
- 4 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
- Acute illness such as infection in the previous 4 weeks
- Unable to safely withdraw medications for mental stress testing
Más betegség
- Severe uncontrolled hypertension >180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- Severe uncontrolled hypertension >180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- Severe uncontrolled hypertension >180/100
- History of percutaneous coronary intervention
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Severe lung, renal, liver, or psychiatric illness
- History of substance abuse
- Significant psychiatric illness that precludes safe participation in the study
- Hypertension, defined as resting BP >120/80
- Diabetes
- Conditions that preclude accurate or safe testing and patient refusal
Laborértékek
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- LDL >120 mg/dL
- Fasting blood glucose >95 mg/dL
Egyéb
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life-expectancy less than 2 years
- Unable to consent
- Obstructive CAD (oCAD) Group
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life expectancy is less than 2 years
- Unable to consent
- Asymptomatic Control Group
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Significant anemia or blood dyscrasia
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- Coronary artery bypass grafting
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Current neoplasm
- Life expectancy is less than 2 years
- Orthopedic limitation that will prevent ETT
- Hyperlipidemia
- Smoking
- Unable to consent
Kiket keres a vizsgálat
- Symptomatic postmenopausal women with chest pain
- age≥45 years old
- willing to undergo cardiac MIBG scan
- willing to undergo mental stress testing
- competent to give informed consent
- Symptomatic postmenopausal women with chest pain who have obstructive CAD in at least one epicardial coronary artery
- willing to undergo cardiac MIBG scan
- willing to undergo mental stress testing
- competent to give informed consent
- Asymptomatic postmenopausal women, age ≥ 45 years old
- Healthy volunteer with no cardiac risk factors
- No history or diagnosis of heart disease
- Not on any cardiac medications
- Normal maximal exercise treadmill stress testing (ETT)
- Fully understanding and willing to undergo mental stress testing
- Willing to sign the informed consent
A regiszterben nem jelölt feltételek
- CMD Group
Életkor a regiszterben: 45 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (4)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Emory Hospital | Atlanta | Egyesült Államok | Toboroz |
| Emory Clinic | Atlanta | Egyesült Államok | Toboroz |
| Emory Hospital Midtown | Atlanta | Egyesült Államok | Toboroz |
| Emory Saint Joseph's Hospital | Atlanta | Egyesült Államok | Toboroz |
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