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NCT05401630 · ClinicalTrials.gov registry record · NA
Mental Stress Reactivity in Women With CMD
A NA study of Postmenopause, sponsored by Emory University.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 4
- Study locations
NCT05401630: Recruiting NA study of Postmenopause, sponsored by Emory University.
NCT05401630 is a NA study of Postmenopause that is actively recruiting participants, run by Emory University. The registered enrollment target is 150 participants, below the 193-participant average among 7 other Postmenopause trials with a reported enrollment target (22% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05401630, a NA study of Postmenopause, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 4
- Study locations
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Study Procedures
Study Locations (4)
Georgia
- Emory Hospital Midtown - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
- Emory Clinic - Atlanta
- Emory Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-07-19 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05401630 shows while recruiting
NCT05401630 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 193-participant average among 7 other Postmenopause trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Postmenopause appearing as the primary indexed condition, and to 1 intervention - of which Study Procedures is the first listed.
NCT05401630 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05401630 about?
NCT05401630 is a clinical study titled "Mental Stress Reactivity in Women With CMD". 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 investi...
What is the current status of trial NCT05401630?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2022-07-19. Estimated completion is 2026-12-31.
What conditions does trial NCT05401630 study?
This clinical trial studies the following conditions: Postmenopause.
What interventions are being tested in trial NCT05401630?
The interventions under investigation include: Study Procedures (OTHER).
Who is sponsoring clinical trial NCT05401630?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05401630 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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