NCT02301663 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
| NCT ID | NCT02301663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Microvascular Coronary Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2014-11 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2014-11 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Fully understanding and willing to undergo study procedures 2. Male or Female greater than or equal to 18 years of age 3. Understanding and willing to sign consent form. Exclusion Criteria: 1. History of cardiovascular, pulmonary, or neurological disease 2. Hypertension (sitting blood pressure \>140/90 mmHg, with measurements recorded on at least 2 occasions) 3. Diabetes 4. Unable to give informed consent; 5. Contra-indication to CMRI testing, including claustrophobia and metallic implants 6. Adherence or retention issues; 7. Women who are pregnant. 8. Allergy to animal dander.
Contact & Investigator
Barbra Streisand Women's Heart Center
📞 310-423-9666
Michael Nelson, PhD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT02301663 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Microvascular Coronary Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02301663 currently recruiting?
Yes, NCT02301663 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cedars-Sinai Medical Center to inquire about joining.
Where is the NCT02301663 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT02301663 clinical trial?
NCT02301663 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Michael Nelson, PhD at Cedars-Sinai Medical Center. The trial plans to enroll 30 participants.