Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging

• Status: Recruiting
• Trial end date: 2025-06-15
• Target enrollment: 0
• Participant gender: All

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 angina in the absence of obstructive CAD who currently remain undiagnosed and untreated. It, therefore, upholds an important part of the mission of the The National Heart, Lung, and Blood Institute (NHLBI), which is to promote the treatment of heart disease and enhance the health of all individuals so that they can live longer and more fulfilling lives.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Adrenergic beta-Antagonists; Calcium; Calcium Channel Blockers; Diltiazem; Nebivolol

Criteria

Inclusion Criteria

1. Age ≥18 years

2. Stable angina (typical or atypical, based on Diamond criteria (35))

3. Exercise stress echocardiogram or exercise stress test (with beta blocker or calcium channel blocker held) performed within six months of enrollment

4. CCTA or invasive coronary angiogram confirming the presence of an MB

5. 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:

1. Asymptomatic

2. Status--post heart transplant

3. Presence of another likely explanation of chest pain, such as pulmonary hypertension, hypertrophic obstructive cardiomyopathy, or aortic stenosis

4. Presence of an acute coronary syndrome (unstable angina, NSTEMI, or STEMI), Tako--tsubo, or cardiogenic shock

5. An abnormal left ventricular ejection fraction (EF<55%)

6. History of a severe adverse reaction to beta blockers or calcium channel blockers (prior minor intolerance or ineffectiveness not exclusion)

7. Use of existing medication that has an unsafe drug--drug interaction with beta blockers or calcium channel blockers

8. Refusal to take beta blockers or calcium channel blockers

9. Resting systolic blood pressure <100 mmHg or heart rate <50 beats per minute

10. Inability to provide an informed consent, including an inability to speak, read, or understand English or Spanish

11. 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

12. A potentially vulnerable subject (including pregnant women, prisoners, economically and educationally disadvantaged, decisionally impaired, and institutionalized individuals)