Microvascular Coronary DysfunctionNCT01568177
Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction
A study testing Mental Stress Testing, Peripheral Arterial Tonometry (PAT) Testing and Heart Rate Variability (HRV) in people with Microvascular Coronary Dysfunction, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microvascular Coronary Dysfunction
- What is being tested?
- Mental Stress Testing, Peripheral Arterial Tonometry (PAT) Testing and Heart Rate Variability (HRV)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with symptomatic angina or angina equivalent;
- Age > 18 yrs old;
- No obstructive CAD at coronary angiography (performed within the previous 24 months);
- Competent to give informed consent.
- Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing);
- No cardiac risk factors by Framingham/NCEP criteria;
- Age (35-65) matched to the WISE MCD population;
- A normal maximal exercise stress test.
Who cannot join
- Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery;
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000);
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG;
- Acute MI;
Show all 22Show fewer
- Prior non-cardiac illness with an estimated life expectancy < 4 years;
- Unable to give informed consent;
- Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
- Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema);
- Women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgement of the operator; Those determined to have flow-obstructing stenosis will be excluded from the overall study;
- Participation in a research study that conflicts with the current WISE study.
- Women with coronary stenosis ≥50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the CRT subgroup.
- Women who are pregnant.
- Males
- Contraindications to CMR testing (metal devices in chest, claustrophobia, known angioedema);
- Contraindication to Adenosine including asthma, heart block (second and third degree) and sinus node disease, significant COPD/asthma, or systemic hypotension (<90mmHg);
- Contraindication to Dobutamine including severe systemic hypertension (≥ 220/120 mmHg), unstable angina, significant aortic valve stenosis, complex cardiac arrhythmia including uncontrolled atrial fibrillation, hypertrophic obstructive cardiomyopathy, myocarditis, endocarditis, pericarditis, or uncontrolled congestive heart failure;
- Contraindication to Gadolinium (renal impairment);
- Any renal disease;
- Pregnant and lactating women;
- Inability to perform exercise, e.g. orthopedic limitations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.
Read the detailed description
There are three groups in this study: 40 MCD subjects with abnormal coronary reactivity testing (CRT), 20 CSX subjects with symptoms and nomral stress testing, and 40 normal controls. Normal controls will complete two study visits while MCD subjects may have up to three study visits.
Recruiting participants from Protocol 14906:
To date, no participants from Protocol 14906 have completed the study yet. All the participants who are currently enrolled in 14906 will be approached by the investigator at their next study visits. Prospectively new participants will be approached while they are consented for 14906.
Recruiting participants from Protocol 11753:
Participants who are currently enrolled in Protocol 11753 will be approached at their next study visits. Prospectively new participants will be approached while they are consented for 11753. Research staff may also identify past patients who have completed 11753 and fulfill the requirements for healthy individuals.
All participants will be asked to undergo research procedures including mental stress tasks, heart rate variability, cold pressor testing, and peripheral arterial tonometry. These procedures are described below by visit:
VISIT ONE:
MENTAL STRESS TESTING Mental Stress Testing will be used to study what happens to heart rate, blood pressure, heart rhythm, and blood vessels in arms and hands when participants are in a stressful situation. It will take up to 3 hours to complete all the procedures in the mental stress testing including the following specific procedures: In Mental Stress Tasks, different types of stress testing, including a speech task over a situation that made participants upset or angry, and/or a math test involving adding or subtracting numbers under a specific constraint, and/or a memory test, will be administered to study the effect of stress on heart; In Heart Rate Variability (HRV), participants will be asked to wear a Holter monitor that measures heart rate and rhythm for approximately 24 hours; In Cold Pressor Testing, participants' heart rate, blood pressure, heart rhythm, and blood vessels will be monitored; In Peripheral Arterial Tonometry (PAT), a blood pressure cuff will be placed on one arm and probes will be placed on participants' fingers. The probes and cuff are attached to a monitoring device that transfers a waveform graph of participants' pulse. Then the blood pressure cuff will be inflated for 5 minutes. At the end of the 5-minute period, the blood pressure cuff will be deflated to get the final tracings.
RESPERATE BREATHING TRIAL In subjects who have MCD, to know whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and to test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress, MCD subjects will be randomized to completing a RESPeRATE breathing trial or performing their own choice of relaxation technique for 8 weeks.
VISIT TWO:
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) CARDIAC SCAN WITH 123I-MIBG AND MYOVIEW Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity. The test will take approximately 5 hours with approximately 3.5 hours of break in the middle.
VISIT THREE:
REPEATED MENTAL STRESS TESTING Only subjects with MCD will have the visit that will take about 3 hours to complete. During this visit, MCD subjects will be asked to complete repeated Mental Stress Testing, including Mental Stress Tasks, Holter Heart Rate Variability, and PAT testing as outlined above
All the procedures are research-related. Participants may consent to some but not all of the procedures due to our current limited funding.
There are no collaborations with other sites.
- Conditions
- Microvascular Coronary Dysfunction
- Being tested
- Mental Stress Testing, Peripheral Arterial Tonometry (PAT) Testing, Heart Rate Variability (HRV), RESPeRATE Breathing Trial, SPECT cardiac scan with 123I-mIBG and Myoview
- Keywords
- MCD
- Medical subject headings
- Macular dystrophy, corneal type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Stress TestingBehavioural
Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.
Peripheral Arterial Tonometry (PAT) TestingOther
PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).
Heart Rate Variability (HRV)Other
Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.
RESPeRATE Breathing TrialOther
RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.
SPECT cardiac scan with 123I-mIBG and MyoviewProcedure or surgery
Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.
| Study group | Role | What they receive |
|---|---|---|
| abnormal CRT | Other | 40 subjects with microvascular coronary dysfunction (MCD) defined as abnormal CRT.
Visits 1, 2, and 3 Receives: Behavioral: Mental Stress Testing; Other: Peripheral Arterial Tonometry (PAT) Testing; Other: Heart Rate Variability (HRV); Other: RESPeRATE Breathing Trial; Procedure: SPECT cardiac scan with 123I-mIBG and Myoview |
| Cardiac Syndrome X | Other | 20 subjects with symptoms and normal stress tests, no MCD. Visits 1 and 2 Receives: Behavioral: Mental Stress Testing; Other: Peripheral Arterial Tonometry (PAT) Testing; Other: Heart Rate Variability (HRV); Other: RESPeRATE Breathing Trial; Procedure: SPECT cardiac scan with 123I-mIBG and Myoview |
| normal reference controls | Other | 40 normal reference controls subjects Visits 1 and 2 Receives: Behavioral: Mental Stress Testing; Other: Peripheral Arterial Tonometry (PAT) Testing; Other: Heart Rate Variability (HRV); Other: RESPeRATE Breathing Trial; Procedure: SPECT cardiac scan with 123I-mIBG and Myoview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Reactivity (CVR)
Cardiovascular Reactivity (CVR)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2024
- Study completionFeb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Coronary DysfunctionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C. Noel Bairey Merz, M.D., Principal investigator, Cedars-Sinai Medical CenterPuja Mehta, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568177
- Sponsor's protocol ID
- 22264
- Status last verified
- Sep 2024
- First submitted
- 29 Mar 2012
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction
- ClinicalTrials.gov ID
- NCT01568177
- Acronym / sponsor ID
- 22264
- Conditions
- Microvascular Coronary Dysfunction
- Keywords
- MCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2024 (actual)
- Study completion
- Feb 2024 (actual)
- First posted
- 2 Apr 2012 (estimated)
- 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.
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.
Detailed description
There are three groups in this study: 40 MCD subjects with abnormal coronary reactivity testing (CRT), 20 CSX subjects with symptoms and nomral stress testing, and 40 normal controls. Normal controls will complete two study visits while MCD subjects may have up to three study visits.
Recruiting participants from Protocol 14906:
To date, no participants from Protocol 14906 have completed the study yet. All the participants who are currently enrolled in 14906 will be approached by the investigator at their next study visits. Prospectively new participants will be approached while they are consented for 14906.
Recruiting participants from Protocol 11753:
Participants who are currently enrolled in Protocol 11753 will be approached at their next study visits. Prospectively new participants will be approached while they are consented for 11753. Research staff may also identify past patients who have completed 11753 and fulfill the requirements for healthy individuals.
All participants will be asked to undergo research procedures including mental stress tasks, heart rate variability, cold pressor testing, and peripheral arterial tonometry. These procedures are described below by visit:
VISIT ONE:
MENTAL STRESS TESTING Mental Stress Testing will be used to study what happens to heart rate, blood pressure, heart rhythm, and blood vessels in arms and hands when participants are in a stressful situation. It will take up to 3 hours to complete all the procedures in the mental stress testing including the following specific procedures: In Mental Stress Tasks, different types of stress testing, including a speech task over a situation that made participants upset or angry, and/or a math test involving adding or subtracting numbers under a specific constraint, and/or a memory test, will be administered to study the effect of stress on heart; In Heart Rate Variability (HRV), participants will be asked to wear a Holter monitor that measures heart rate and rhythm for approximately 24 hours; In Cold Pressor Testing, participants' heart rate, blood pressure, heart rhythm, and blood vessels will be monitored; In Peripheral Arterial Tonometry (PAT), a blood pressure cuff will be placed on one arm and probes will be placed on participants' fingers. The probes and cuff are attached to a monitoring device that transfers a waveform graph of participants' pulse. Then the blood pressure cuff will be inflated for 5 minutes. At the end of the 5-minute period, the blood pressure cuff will be deflated to get the final tracings.
RESPERATE BREATHING TRIAL In subjects who have MCD, to know whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and to test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress, MCD subjects will be randomized to completing a RESPeRATE breathing trial or performing their own choice of relaxation technique for 8 weeks.
VISIT TWO:
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) CARDIAC SCAN WITH 123I-MIBG AND MYOVIEW Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity. The test will take approximately 5 hours with approximately 3.5 hours of break in the middle.
VISIT THREE:
REPEATED MENTAL STRESS TESTING Only subjects with MCD will have the visit that will take about 3 hours to complete. During this visit, MCD subjects will be asked to complete repeated Mental Stress Testing, including Mental Stress Tasks, Holter Heart Rate Variability, and PAT testing as outlined above
All the procedures are research-related. Participants may consent to some but not all of the procedures due to our current limited funding.
There are no collaborations with other sites.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| abnormal CRT | Other | Behavioral: Mental Stress Testing, Other: Peripheral Arterial Tonometry (PAT) Testing, Other: Heart Rate Variability (HRV), Other: RESPeRATE Breathing Trial, Procedure: SPECT cardiac scan with 123I-mIBG and Myoview40 subjects with microvascular coronary dysfunction (MCD) defined as abnormal CRT. Visits 1, 2, and 3 |
| Cardiac Syndrome X | Other | Behavioral: Mental Stress Testing, Other: Peripheral Arterial Tonometry (PAT) Testing, Other: Heart Rate Variability (HRV), Other: RESPeRATE Breathing Trial, Procedure: SPECT cardiac scan with 123I-mIBG and Myoview20 subjects with symptoms and normal stress tests, no MCD. Visits 1 and 2 |
| normal reference controls | Other | Behavioral: Mental Stress Testing, Other: Peripheral Arterial Tonometry (PAT) Testing, Other: Heart Rate Variability (HRV), Other: RESPeRATE Breathing Trial, Procedure: SPECT cardiac scan with 123I-mIBG and Myoview40 normal reference controls subjects Visits 1 and 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with symptomatic angina or angina equivalent;
- Age > 18 yrs old;
- No obstructive CAD at coronary angiography (performed within the previous 24 months);
- Competent to give informed consent.
- Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing);
Key exclusion criteria (22 listed)
- Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery;
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000);
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG;
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 |
|---|---|---|
| Mental Stress TestingMental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women. | Behavioural | Cardiac Syndrome X, abnormal CRT, normal reference controls |
| Peripheral Arterial Tonometry (PAT) TestingPAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd). | Other | Cardiac Syndrome X, abnormal CRT, normal reference controls |
| Heart Rate Variability (HRV)Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours. | Other | Cardiac Syndrome X, abnormal CRT, normal reference controls |
| RESPeRATE Breathing TrialRESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress. | Other | Cardiac Syndrome X, abnormal CRT, normal reference controls |
| SPECT cardiac scan with 123I-mIBG and MyoviewSingle Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity. | Procedure or surgery | Cardiac Syndrome X, abnormal CRT, normal reference controls |
Primary outcome
Cardiovascular Reactivity (CVR)
Time frame: 24 hours
Cardiovascular Reactivity (CVR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
C. Noel Bairey Merz, M.D. principal investigator
Cedars-Sinai Medical Center
Puja Mehta, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Stress Testing, Peripheral Arterial Tonometry (PAT) Testing and Heart Rate Variability (HRV) in people with Microvascular Coronary Dysfunction, run by Cedars-Sinai Medical Center at 1 site 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 8 inclusion and 22 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Reactivity (CVR) (time frame: 24 hours). 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 19 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.