Post-menopauseNCT05401630
Mental Stress Reactivity in Women With CMD
A study testing Study Procedures in people with Post-menopause, run by Emory University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Post-menopause
- What is being tested?
- Study Procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Jul 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 78Show fewer
- 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
- 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)
- 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
- 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)
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Puja K Mehta, MD contact
United States4 sites, 4 recruiting
- Recruiting
Emory Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
- Recruiting
Emory Clinic
Atlanta, Georgia, 30322
- Recruiting
Emory Hospital
Atlanta, Georgia, 30322
About this study
Official title: Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
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.
Read the detailed description
The overall goal of this project is to clarify the mechanisms and pathophysiology of how psychological stress contributes to Major Adverse Cardiovascular Events (MACE) in women despite having no obstructive CAD. Through this proposal, the research team expects to have an improved understanding of the relationships between mental stress and coronary microvascular dysfunction in women.
One-third to one-half of women with chest pain who are suspected of having myocardial ischemia and undergo coronary angiography are actually found to have no obstructive coronary artery disease (CAD) (<50% luminal stenosis) and thus are often reassured and dismissed without a cardiac diagnosis or therapy. Current evidence suggests that a large proportion of these women have coronary microvascular dysfunction (CMD) and are at significantly increased risk of major adverse cardiovascular events (MACE), including myocardial infarction, heart failure, and sudden cardiac death. However, because of substantial knowledge gaps, these patients also have recurrent hospitalizations for chest pain, reduced health-related quality of life, and comparable disability and healthcare costs to obstructive CAD patients. Cardiac rest/stress positron emission tomography (PET) imaging can detect impaired myocardial flow reserve (MFR) and diagnose CMD. However, therapeutic strategies are poorly developed, with limited studies to inform clinicians on the treatment of CMD.
Comorbid psychological factors such as anxiety and depression are prevalent in women with persistent angina, and stress can contribute to and exacerbate angina, implicating the autonomic nervous system (ANS) as one mechanistic pathway in CMD-related ischemia and MACE. The preliminary data indicate that women with CMD have ANS dysfunction with sympathetic predominance compared to non-CMD controls. The research team has shown that women have more mental stress ischemia (MSI) and stress-induced peripheral microvascular vasoconstriction compared to men. MSI is an important prognostic marker with an estimated two-fold increase in MACE, including mortality, regardless of the severity of CAD.
The research team posits that an improved understanding of psychological stress reactivity in CMD patients will help tease out the underlying mechanisms contributing to adverse outcomes in CMD-related ischemia and provide new treatment targets to reduce symptom burden and MACE. The overall goal of this project is to clarify the mechanisms and pathophysiology of how psychological stress contributes to MACE in women despite having no obstructive CAD. The research team has also shown that coronary microvascular responses to mental stress are reflected in the peripheral microvascular circulation. This proposal addresses an important knowledge gap in an understudied population and is a direct extension of their prior work. Findings from this work have the potential to inform therapeutic strategies in CMD, a problem that impacts an estimated 3 million American women. The unifying hypothesis is that women with CMD have exaggerated sympathetic activation and abnormal vasoreactivity to mental stress, which predisposes them to adverse outcomes even in the absence of obstructive CAD.
Three groups of post-menopausal women will be compared: (1) symptomatic women with no obstructive CAD who have CMD ; (2) symptomatic women with chronic obstructive CAD (oCAD); and (3) asymptomatic control women with no prior history of CAD or angina, who are age-matched to the CMD women. The oCAD group will serve as a comparison group since these women represent the prevailing paradigm of ischemia from obstructive stenosis while sharing common cardiovascular risk factors that could confound the findings.
No study has comprehensively characterized mental stress reactivity by pairing autonomic responses and vascular reactivity in women with CMD, and with follow-up of angina and quality of life (QoL). This study would provide critical data on the clinical significance of these measures in the CMD population.
- Conditions
- Post-menopause
- Being tested
- Study Procedures
- Keywords
- Microvascular, Sympathetic activity, Mental Stress, Angina
- Medical subject headings
- Stress, Psychological, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProceduresOther
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.
All 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.
A 3-day food recall diary, cognitive assessments via the NIH Toolbox, and a Sleep diary during home monitoring will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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 < 2.5) Receives: Other: Study Procedures |
| Symptomatic women with chronic obstructive CAD (oCAD) | Experimental | 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. Receives: Other: Study Procedures |
| 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. Receives: Other: Study Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planar late Heart to Mediastinal Ratio (MIBG imaging)
The research team will compare resting sympathetic activity measured with 123I-meta-iodobenzylguanidine (MIBG) imaging between CMD women and the two control groups. The heart to the mediastinal ratio (HMR) which is an index of MIBG uptake will be calculated as per standard methods. The HMR reflects norepinephrine kinetics. Higher sympathetic activity and turnover cause less MIBG to be retained and result in a lower HMR. MIBG SPECT defect score will be determined by late (4 hours) MIBG uptake by visual blind scoring using the standard 17-segment model with 0=normal tracer uptake, 1=mildly reduced uptake, 2=moderately reduced uptake, 3=severely reduced uptake, 4=absent tracer uptake, as defined by Bax et al.
Measured: At the end of MIBG procedure
Changes in HRV with mental stress
The research team will also compare autonomic reactivity during a standardized mental stress test, including heart rate variability (HRV) between CMD women and the two control groups
Measured: Baseline (prior to stress testing) and during mental stress test
Changes in pre-ejection period (PEP) with mental stress
The research team will also compare autonomic reactivity during a standardized mental stress test, including the pre-ejection period (PEP) between CMD women and the two control groups. This measures systolic time interval and reflects cardiac contractility (which is under the beta-adrenergic influence). Impedance ECG measures PEP from the onset of ventricular depolarization (Q-wave on ECG) to the opening of the aortic valve for ejection of blood from the left ventricle.
Measured: Baseline (prior to stress testing) and during mental stress test
Secondary outcomes (3)
Changes in flow mediated dilation (FMD test) to acute mental stress in CMD women.
The research team will compare peripheral microvascular vasoconstriction during mental stress, as well as changes in peripheral microvascular function and flow-mediated dilation with mental stress, between CMD women and the two control groups. Readings of blood flow in one of the arteries of the arm using an ultrasound. Then a blood pressure cuff will be placed around the forearm and will be inflated to stop the flow of blood for 5 minutes. After 5 minutes, the blood pressure cuff will be deflated and the readings taken again.
Measured: Baseline (prior to stress testing) and at the end of the mental stress test
Changes in Peripheral arterial tonometry (PAT) test to acute mental stress in CMD women.
The research team will compare peripheral microvascular vasoconstriction during mental stress, as well as changes in peripheral microvascular function and flow-mediated dilation with mental stress, between CMD women and the two control groups. A blood pressure cuff will be placed on one arm, and probes will be placed on the fingers. In order to get a good tracing, the participant will need to remain quiet and very still for at least 5 minutes. Then, the blood pressure cuff will be inflated for 5 minutes, and more recordings will be done. At the end of the 5 minutes, the blood pressure cuff will be deflated, but to obtain the final tracings, the participant should lie still for another 5-10 minutes.
Measured: Baseline (prior to stress testing) and at the end of the mental stress test
Examine whether chronic stress burden and autonomic dysfunction during daily life is elevated in CMD women.
The research team will compare anginal symptoms, chronic and daily life stress, and autonomic function measured during one week of home monitoring between CMD and the two control groups. Participants will use a smartphone to track their symptoms and stress.
Measured: At the end of 1 week of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start19 Jul 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopauseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Puja Mehta, Emory University
- Investigators
- Puja K Mehta, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401630
- Sponsor's protocol ID
- STUDY00003154
- Other IDs
- 1R01HL157311-01A1, 2025P012678
- Status last verified
- Oct 2026
- First submitted
- 10 May 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share de-identified group demographic data and outcomes with the sponsor and other researchers who request access.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Stress Reactivity in Women With Coronary Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT05401630
- Acronym / sponsor ID
- STUDY00003154
- Conditions
- Post-menopause
- Keywords
- Microvascular, Sympathetic activity, Mental Stress, Angina
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this project is to clarify the mechanisms and pathophysiology of how psychological stress contributes to Major Adverse Cardiovascular Events (MACE) in women despite having no obstructive CAD. Through this proposal, the research team expects to have an improved understanding of the relationships between mental stress and coronary microvascular dysfunction in women.
One-third to one-half of women with chest pain who are suspected of having myocardial ischemia and undergo coronary angiography are actually found to have no obstructive coronary artery disease (CAD) (<50% luminal stenosis) and thus are often reassured and dismissed without a cardiac diagnosis or therapy. Current evidence suggests that a large proportion of these women have coronary microvascular dysfunction (CMD) and are at significantly increased risk of major adverse cardiovascular events (MACE), including myocardial infarction, heart failure, and sudden cardiac death. However, because of substantial knowledge gaps, these patients also have recurrent hospitalizations for chest pain, reduced health-related quality of life, and comparable disability and healthcare costs to obstructive CAD patients. Cardiac rest/stress positron emission tomography (PET) imaging can detect impaired myocardial flow reserve (MFR) and diagnose CMD. However, therapeutic strategies are poorly developed, with limited studies to inform clinicians on the treatment of CMD.
Comorbid psychological factors such as anxiety and depression are prevalent in women with persistent angina, and stress can contribute to and exacerbate angina, implicating the autonomic nervous system (ANS) as one mechanistic pathway in CMD-related ischemia and MACE. The preliminary data indicate that women with CMD have ANS dysfunction with sympathetic predominance compared to non-CMD controls. The research team has shown that women have more mental stress ischemia (MSI) and stress-induced peripheral microvascular vasoconstriction compared to men. MSI is an important prognostic marker with an estimated two-fold increase in MACE, including mortality, regardless of the severity of CAD.
The research team posits that an improved understanding of psychological stress reactivity in CMD patients will help tease out the underlying mechanisms contributing to adverse outcomes in CMD-related ischemia and provide new treatment targets to reduce symptom burden and MACE. The overall goal of this project is to clarify the mechanisms and pathophysiology of how psychological stress contributes to MACE in women despite having no obstructive CAD. The research team has also shown that coronary microvascular responses to mental stress are reflected in the peripheral microvascular circulation. This proposal addresses an important knowledge gap in an understudied population and is a direct extension of their prior work. Findings from this work have the potential to inform therapeutic strategies in CMD, a problem that impacts an estimated 3 million American women. The unifying hypothesis is that women with CMD have exaggerated sympathetic activation and abnormal vasoreactivity to mental stress, which predisposes them to adverse outcomes even in the absence of obstructive CAD.
Three groups of post-menopausal women will be compared: (1) symptomatic women with no obstructive CAD who have CMD ; (2) symptomatic women with chronic obstructive CAD (oCAD); and (3) asymptomatic control women with no prior history of CAD or angina, who are age-matched to the CMD women. The oCAD group will serve as a comparison group since these women represent the prevailing paradigm of ischemia from obstructive stenosis while sharing common cardiovascular risk factors that could confound the findings.
No study has comprehensively characterized mental stress reactivity by pairing autonomic responses and vascular reactivity in women with CMD, and with follow-up of angina and quality of life (QoL). This study would provide critical data on the clinical significance of these measures in the CMD population.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic women with no obstructive CAD who have CMD | Experimental | Other: Study ProceduresSymptomatic women with chest pain and no obstructive CAD who have an abnormal myocardial flow reserve (MFR < 2.5) |
| Symptomatic women with chronic obstructive CAD (oCAD) | Experimental | Other: Study ProceduresThis 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. |
| Asymptomatic control women with no prior history of CAD or angina | Active comparator | Other: Study ProceduresAsymptomatic 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (78 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study ProceduresAll 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. All 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. A 3-day food recall diary, cognitive assessments via the NIH Toolbox, and a Sleep diary during home monitoring will be collected. | Other | Asymptomatic control women with no prior history of CAD or angina, Symptomatic women with chronic obstructive CAD (oCAD), Symptomatic women with no obstructive CAD who have CMD |
Primary outcome
Planar late Heart to Mediastinal Ratio (MIBG imaging)
Time frame: At the end of MIBG procedure
The research team will compare resting sympathetic activity measured with 123I-meta-iodobenzylguanidine (MIBG) imaging between CMD women and the two control groups. The heart to the mediastinal ratio (HMR) which is an index of MIBG uptake will be calculated as per standard methods. The HMR reflects norepinephrine kinetics. Higher sympathetic activity and turnover cause less MIBG to be retained and result in a lower HMR. MIBG SPECT defect score will be determined by late (4 hours) MIBG uptake by visual blind scoring using the standard 17-segment model with 0=normal tracer uptake, 1=mildly reduced uptake, 2=moderately reduced uptake, 3=severely reduced uptake, 4=absent tracer uptake, as defined by Bax et al.
Changes in HRV with mental stress
Time frame: Baseline (prior to stress testing) and during mental stress test
The research team will also compare autonomic reactivity during a standardized mental stress test, including heart rate variability (HRV) between CMD women and the two control groups
Changes in pre-ejection period (PEP) with mental stress
Time frame: Baseline (prior to stress testing) and during mental stress test
The research team will also compare autonomic reactivity during a standardized mental stress test, including the pre-ejection period (PEP) between CMD women and the two control groups. This measures systolic time interval and reflects cardiac contractility (which is under the beta-adrenergic influence). Impedance ECG measures PEP from the onset of ventricular depolarization (Q-wave on ECG) to the opening of the aortic valve for ejection of blood from the left ventricle.
3 secondary outcomes
Changes in flow mediated dilation (FMD test) to acute mental stress in CMD women.
Time frame: Baseline (prior to stress testing) and at the end of the mental stress test
Changes in Peripheral arterial tonometry (PAT) test to acute mental stress in CMD women.
Time frame: Baseline (prior to stress testing) and at the end of the mental stress test
Examine whether chronic stress burden and autonomic dysfunction during daily life is elevated in CMD women.
Time frame: At the end of 1 week of monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. The research team will share de-identified group demographic data and outcomes with the sponsor and other researchers who request access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Puja K Mehta, MD contact
Puja K Mehta principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Procedures in people with Post-menopause, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 78 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Puja K Mehta, MD (404-712-0281, pkmehta@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Planar late Heart to Mediastinal Ratio (MIBG imaging) (time frame: At the end of MIBG procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.