Status:
TERMINATED
Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging
Lead Sponsor:
Stanford University
Conditions:
Myocardial Bridging
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The proposed clinical trial is relevant to public health because it is expected to expand the differential diagnosis and provide an evidence--based therapy for the large population of patients with an...
Detailed Description
Angina in the absence of obstructive coronary artery disease (CAD) affects millions, resulting in a reduced quality of life and a burden on the health care system. Previous work has focused on endothe...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥18 years
- Stable angina (typical or atypical, based on Diamond criteria (35))
- Exercise stress echocardiogram or exercise stress test (with beta blocker or calcium channel blocker held) performed within six months of enrollment
- CCTA or invasive coronary angiogram confirming the presence of an MB
- Absence of obstructive CAD, as demonstrated by no ischemia on stress testing and no significant obstructive CAD (coronary stenosis \<50%) on CCTA or invasive coronary angiogram
- Exclusion Criteria:
- Asymptomatic
- Status--post heart transplant
- Presence of another likely explanation of chest pain, such as pulmonary hypertension, hypertrophic obstructive cardiomyopathy, or aortic stenosis
- Presence of an acute coronary syndrome (unstable angina, NSTEMI, or STEMI), Tako--tsubo, or cardiogenic shock
- An abnormal left ventricular ejection fraction (EF\<55%)
- History of a severe adverse reaction to beta blockers or calcium channel blockers (prior minor intolerance or ineffectiveness not exclusion)
- Use of existing medication that has an unsafe drug--drug interaction with beta blockers or calcium channel blockers
- Refusal to take beta blockers or calcium channel blockers
- Resting systolic blood pressure \<100 mmHg or heart rate \<50 beats per minute
- Inability to provide an informed consent, including an inability to speak, read, or understand English or Spanish
- A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent
- A potentially vulnerable subject (including pregnant women, prisoners, economically and educationally disadvantaged, decisionally impaired, and institutionalized individuals)
Exclusion
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04130438
Start Date
October 15 2020
End Date
October 17 2024
Last Update
February 25 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305