Microvascular Coronary DysfunctionNCT02301663
Development of a Novel Stress Testing Protocol to Define the Relationship Between Coronary Microvascular Dysfunction and Diastology in Women With Angina But No Evidence of Obstructive Coronary Artery Disease
A study testing Handgrip, Altitude simulation and Leg exercise 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, primarily 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 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microvascular Coronary Dysfunction
- What is being tested?
- Handgrip, Altitude simulation and Leg exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2030
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understanding and willing to undergo study procedures
- Male or Female greater than or equal to 18 years of age
- Understanding and willing to sign consent form.
Who cannot join
- History of cardiovascular, pulmonary, or neurological disease
- Hypertension (sitting blood pressure >140/90 mmHg, with measurements recorded on at least 2 occasions)
- Diabetes
- Unable to give informed consent;
- Contra-indication to CMRI testing, including claustrophobia and metallic implants
- Adherence or retention issues;
- Women who are pregnant.
- Allergy to animal dander.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbra Streisand Women's Heart Center contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Nicole Tovar, 310-248-6960, nicole.tovar@cshs.org
BS WHC, MS, 310-423-9666, bswhc.research@cshs.org
About this study
Official title: DEVELOPMENT OF A NOVEL STRESS TESTING PROTOCOL TO DEFINE THE RELATIONSHIP BETWEEN CORONARY MICROVASCULAR DYSFUNCTION AND DIASTOLOGY IN WOMEN WITH ANGINA BUT NO EVIDENCE OF OBSTRUCTIVE CORONARY ARTERY DISEASE
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
- Conditions
- Microvascular Coronary Dysfunction
- Being tested
- Handgrip, Altitude simulation, Leg exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HandgripOther
Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
Altitude simulationOther
Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
Leg exerciseOther
Subjects will perform leg exercise to increase metabolic demand.
| Study group | Role | What they receive |
|---|---|---|
| Women w/microvascular disease | Experimental | 10 women with microvascular disease Receives: Other: Handgrip; Other: Altitude simulation; Other: Leg exercise |
| Normal controls | Experimental | 10 age-matched women with no evidence of microvascular disease Receives: Other: Handgrip; Other: Altitude simulation; Other: Leg exercise |
| calibration | Experimental | 10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers. Receives: Other: Handgrip; Other: Altitude simulation; Other: Leg exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic function by MRI
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 posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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
- 30 participants (estimated)
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
- Michael Nelson, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301663
- Sponsor's protocol ID
- Diastolic stress testing
- Status last verified
- Aug 2023
- First submitted
- 22 Nov 2014
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEVELOPMENT OF A NOVEL STRESS TESTING PROTOCOL TO DEFINE THE RELATIONSHIP BETWEEN CORONARY MICROVASCULAR DYSFUNCTION AND DIASTOLOGY IN WOMEN WITH ANGINA BUT NO EVIDENCE OF OBSTRUCTIVE CORONARY ARTERY DISEASE
- ClinicalTrials.gov ID
- NCT02301663
- Acronym / sponsor ID
- Diastolic stress testing
- Conditions
- Microvascular Coronary Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Nov 2014 (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, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women w/microvascular disease | Experimental | Other: Handgrip, Other: Altitude simulation, Other: Leg exercise10 women with microvascular disease |
| Normal controls | Experimental | Other: Handgrip, Other: Altitude simulation, Other: Leg exercise10 age-matched women with no evidence of microvascular disease |
| calibration | Experimental | Other: Handgrip, Other: Altitude simulation, Other: Leg exercise10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fully understanding and willing to undergo study procedures
- Male or Female greater than or equal to 18 years of age
- Understanding and willing to sign consent form.
Key exclusion criteria (8 listed)
- History of cardiovascular, pulmonary, or neurological disease
- Hypertension (sitting blood pressure >140/90 mmHg, with measurements recorded on at least 2 occasions)
- Diabetes
- Unable to give informed consent;
- Contra-indication to CMRI testing, including claustrophobia and metallic implants
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 |
|---|---|---|
| HandgripSubjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand | Other | Normal controls, Women w/microvascular disease, calibration |
| Altitude simulationSubjects will breathe a lower concentration of oxygen to simulate the effects of altitude. | Other | Normal controls, Women w/microvascular disease, calibration |
| Leg exerciseSubjects will perform leg exercise to increase metabolic demand. | Other | Normal controls, Women w/microvascular disease, calibration |
Primary outcome
Diastolic function by MRI
Time frame: 24 hours
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 1 Sep 2023.
- Individual participant dataSharing planned: Yes
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The DISCOVER INOCA Prospective Multi-center Registry
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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.
Barbra Streisand Women's Heart Center contact
Michael Nelson, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip, Altitude simulation and Leg exercise 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 3 inclusion and 8 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 1 Sep 2023. 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?
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 Barbra Streisand Women's Heart Center (310-423-9666), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic function by MRI (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 1 Sep 2023.