Symptomatic women with no obstructive CAD who have CMD for Menopause

Emory Saint Joseph's Hospital, Atlanta, GA
Study ProceduresN/ARecruitingLed by Puja K MehtaResearch Sponsored by Emory University

Study Summary

This trialaims to investigate the stress response of women with Coronary Microvascular Dysfunction (CMD) and how it affects their heart, blood vessels, and autonomic nervous system.

Eligible Conditions
  • Menopause

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are comfortable with participating in tests that may cause mental stress.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in HRV with mental stress
Changes in pre-ejection period (PEP) with mental stress
Planar late Heart to Mediastinal Ratio (MIBG imaging)
Secondary outcome measures
Changes in Peripheral arterial tonometry (PAT) test to acute mental stress in CMD women.
Changes in flow mediated dilation (FMD test) to acute mental stress in CMD women.
Examine whether chronic stress burden and autonomic dysfunction during daily life is elevated in CMD women.
Other outcome measures
Assessment of general health status
Assessment of quality of life and relationship to anginal symptoms
Changes in catecholamines (norepinephrine and epinephrine) with mental stress among the three groups.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Symptomatic women with no obstructive CAD who have CMDExperimental Treatment1 Intervention
Symptomatic women with chest pain and no obstructive CAD who have an abnormal myocardial flow reserve (MFR < 2.5)
Group II: Symptomatic women with chronic obstructive CAD (oCAD)Experimental Treatment1 Intervention
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.
Group III: Asymptomatic control women with no prior history of CAD or anginaActive Control1 Intervention
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.

Find a site

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,574 Previous Clinical Trials
2,879,593 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,713 Previous Clinical Trials
47,168,799 Total Patients Enrolled
13 Trials studying Menopause
123,075 Patients Enrolled for Menopause
Puja K MehtaPrincipal Investigator
Emory University

Media Library

Symptomatic women with no obstructive CAD who have CMD Clinical Trial Eligibility Overview. Trial Name: NCT05401630 — N/A
Menopause Research Study Groups: Symptomatic women with no obstructive CAD who have CMD, Symptomatic women with chronic obstructive CAD (oCAD), Asymptomatic control women with no prior history of CAD or angina
Menopause Clinical Trial 2023: Symptomatic women with no obstructive CAD who have CMD Highlights & Side Effects. Trial Name: NCT05401630 — N/A
Symptomatic women with no obstructive CAD who have CMD 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals over the age of 64 being considered for participation in this experiment?

"This research program is recruiting individuals who have surpassed the age of 45 and are not yet 100 years old."

Answered by AI

What is the maximum capacity of participants for this study?

"Correct. The information hosted on attests to the fact that this medical trial is recruiting volunteers, having been first posted on July 19th 2022 and last modified on December 7th 2022. Approximately 150 participants are needed from 4 various locations."

Answered by AI

Is this trial recruiting participants currently?

"Affirmative. Information found on demonstrates that this investigation is currently looking for participants, having been first posted in July 2022 and most recently updated in December of the same year. The trial requires a total of 150 patients from 4 distinct research sites."

Answered by AI

Am I eligible to take part in this research study?

"This medical experiment is looking to recruit 150 post-menopausal individuals between 45 and 100 years of age. The inclusion criteria for the trial involve being part of a CMD Group, suffering from chest pains, over 50 years old, willing to submit to MIBG scans and mental stress testing, with the capacity to provide informed consent."

Answered by AI
~100 spots leftby Sep 2026