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Stress Response Study for Heart Issues

Q: 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.

Q: What is the maximum capacity of participants for this study?

Correct. The information hosted on clinicaltrials.gov 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.

Q: Is this trial recruiting participants currently?

Affirmative. Information found on clinicaltrials.gov 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.

Q: 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.

N/A

Recruiting

Led By Puja K Mehta

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteer with no cardiac risk factors

No history or diagnosis of heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

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.

Who is the study for?

This trial is for women over 50 with menopause-related chest pain and Coronary Microvascular Dysfunction (CMD), who can consent to tests. They must be willing to undergo a cardiac scan, mental stress testing, and have no acute illnesses or diabetes. Excluded are those with severe heart issues, uncontrolled hypertension, recent heart attacks, certain blood conditions, or significant artery blockages.Check my eligibility

What is being tested?

The study investigates how mental stress affects the autonomic function in postmenopausal women with CMD compared to others. It involves physical exams, blood tests, imaging of the heart and vessels, plus home monitoring of autonomic function and daily stress levels for one week.See study design

What are the potential side effects?

Since this trial focuses on non-invasive procedures like scans and monitoring rather than medication or surgical interventions, side effects may include discomfort from exercise tests or anxiety during mental stress testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy with no heart disease risk factors.

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I have never been diagnosed with heart disease.

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I understand the information given to me and can make decisions about my health care.

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I am 50 years old or older.

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I am a postmenopausal woman experiencing chest pain.

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I am willing to have a heart scan.

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I am not taking any heart medications.

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I am a woman over 50 and have gone through menopause without symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

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

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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,444 Total Patients Enrolled

13 Trials studying Menopause

123,075 Patients Enrolled for Menopause

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,496 Total Patients Enrolled

Puja K MehtaPrincipal InvestigatorEmory 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 clinicaltrials.gov 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 clinicaltrials.gov 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

Recent research and studies

clinicaltrials.govStudy

Mental Stress Reactivity in Women With CMD

Puja Mehta 2022. "Mental Stress Reactivity in Women With CMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05401630.

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