Post-menopause study: Study Procedures
Official title Mental Stress Reactivity in Women With CMD
ClinicalTrials.gov ID: NCT05401630
What this study is testing
- What it's testing
- The study aims to find out if women with coronary microvascular dysfunction react differently to mental stress than other groups. It also looks at how daily stress impacts the heart and blood vessels.
- Who it's for
- The study is looking for post-menopausal women who have problems with the small blood vessels in their heart.
- What's involved
- Participants will have physical exams, blood tests, stress tests, and heart scans. They will also wear home devices for one week to track their heart activity, sleep, and mood.
- Time commitment
- The study involves a one-week period of home monitoring along with scheduled clinic visits for tests and exams.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, women only
You may be able to join if
- CMD Group
- Symptomatic postmenopausal women with chest pain
- age≥45 years old
- willing to undergo cardiac MIBG scan
- willing to undergo mental stress testing
You likely can't join if
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis...
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Significant anemia or blood dyscrasia
- Severe uncontrolled hypertension \>180/100
- Unable to lie flat for mental stress testing
See the full eligibility criteria
Who can join
- CMD Group
- 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
What rules you out
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Significant anemia or blood dyscrasia
- Severe uncontrolled hypertension \>180/100
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- History of percutaneous coronary intervention
- Coronary artery bypass grafting
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Severe lung, renal, liver, or psychiatric illness
- Current neoplasm
- History of substance abuse
- Acute illness such as infection in the previous 4 weeks
- Life-expectancy less than 2 years
- Unable to safely withdraw medications for mental stress testing
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- 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
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Significant anemia or blood dyscrasia
- Severe uncontrolled hypertension \>180/100
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- History of percutaneous coronary intervention
- Coronary artery bypass grafting
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Severe lung, renal, liver, or psychiatric illness
- Current neoplasm
- History of substance abuse
- Acute illness such as infection in the previous 4 weeks
- Life expectancy is less than 2 years
- Unable to safely withdraw medications for mental stress testing
- Significant psychiatric illness that precludes safe participation in the study
- Conditions that preclude accurate or safe testing and patient refusal
- 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
- Significant epicardial stenosis (defined by coronary stenosis ≥ 70% in any epicardial coronary artery or hemodynamically significant stenosis determined by fractional flow reserve)
- Left ventricular systolic dysfunction (ejection fraction ≤ 50%)
- Heart failure with a preserved ejection fraction
- Significant anemia or blood dyscrasia
- Severe uncontrolled hypertension \>180/100
- Unable to lie flat for mental stress testing
- Pre-menopausal
- Pregnant
- Pericarditis/myocarditis
- History of percutaneous coronary intervention
- Coronary artery bypass grafting
- Acute myocardial infarction/acute coronary syndrome/unstable angina within 1 month
- Significant valvular disease, including aortic or mitral stenosis
- Sinus node dysfunction/pacemaker, 2nd or 3rd-degree atrioventricular block
- Severe lung, renal, liver, or psychiatric illness
- Current neoplasm
- History of substance abuse
- Acute illness such as infection in the previous 4 weeks
- Life expectancy is less than 2 years
- Unable to safely withdraw medications for mental stress testing
- Significant psychiatric illness that precludes safe participation in the study
- Orthopedic limitation that will prevent ETT
- LDL \>120 mg/dL
- Fasting blood glucose \>95 mg/dL
- Hypertension, defined as resting BP \>120/80
- Diabetes
- Hyperlipidemia
- Smoking
- Conditions that preclude accurate or safe testing and patient refusal
- Unable to consent
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.