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

2019-10-23 13:11:49 | BioPortfolio


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.


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 endothelial and microvascular dysfunction as causes of angina in these patients, but even when these etiologies are tested for, nearly half of patients remain undiagnosed, and proven therapies are lacking. The long--term goal of this research proposal is to improve the lives of patients with angina in the absence of obstructive CAD. These patients have been found to have a disproportionate prevalence of myocardial bridges (MBs) (60% vs. 30% in the general population).

MBs are known to cause angina, and the mechanism by which they do so is also known, but MBs have not been actively studied in the context of patients with angina in the absence of obstructive CAD. Medical therapies for symptomatic MBs, including beta blockers and calcium channel blocker have been suggested, but have never been appropriately tested, and may not be better than placebo. The overall objective of this research proposal is to demonstrate that MBs are an important and treatable cause of angina in patients with non--obstructive CAD.

The investigator will conduct the first--ever randomized, double--blind, placebo--controlled trial of medical therapy in patients with angina and an MB. The rationale is that a proven treatment would significantly expand the paradigm by which patients with angina in the absence of obstructive CAD are evaluated and treated. Our central hypothesis is that beta blockers and calcium channel blockers are effective treatments for reducing angina in patients with an MB compared with placebo. Guided by strong preliminary data, this hypothesis will be tested by pursuing two specific aims: 1) Determine the efficacy of beta blockers and calcium channel blockers in treating patients with angina and an MB and 2) Identify predictors of efficacy of beta blockers and calcium channel blockers in treating patients with angina and an MB. For Aim #1, the investigator will randomize a total of 360 adult patients with angina and an MB into one of three treatment arms: beta blocker (nebivolol), calcium channel blocker (diltiazem), or placebo (1:1:1).

Efficacy will be determined after 30 days on the study drug by a change in angina, as assessed by the Seattle Angina Questionnaire (SAQ). The investigator will also evaluate changes in exercise capacity, as well as drug adherence and side effects. For Aim #2, the investigator will evaluate MB muscle index (MMI, a product of MB length x depth) by coronary computed tomography angiography, as well as male sex, as predictors of efficacy. Randomization will be stratified on sex, ensuring a balance of women and men in each arm. The proposed research is innovative because it shifts the current clinical perspective on angina in the absence of obstructive CAD by considering myocardial bridging as a potential etiology.

It is also significant because it will substantially increase the number of patients with angina in the absence of obstructive CAD that clinicians are able to diagnose and treat, ultimately leading to improvements in quality of life and a reduction in health care costs.

Study Design


Myocardial Bridging


Nebivolol, Diltiazem, Placebo


Stanford University
Palo Alto
United States


Not yet recruiting


Stanford University

Results (where available)

View Results


Published on BioPortfolio: 2019-10-23T13:11:49-0400

Clinical Trials [1079 Associated Clinical Trials listed on BioPortfolio]

Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard...

Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine

Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.

Nebivolol in Patients With Systolic Stage 2 Hypertension

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm

The correlation between endothelial dysfunction and the risk of coronary heart disease is well known through previous studies. The degradation of the function of nitric oxide acting on the...

PubMed Articles [2493 Associated PubMed Articles listed on BioPortfolio]

Clinical Outcomes of Surgical Unroofing of Myocardial Bridging in Symptomatic Patients.

There is a paucity of data regarding results of surgical management of myocardial bridging. Our objective was to evaluate the clinical outcomes of unroofing procedures in patients with myocardial brid...

Nebivolol improves obesity-induced vascular remodelling by suppressing NLRP3 activation.

Nebivolol is a novel β-adrenergic receptor (β-AR) blocker with anti-inflammatory and antioxidant properties. The NLRP3 inflammasome plays a pivotal role in the pathogenesis of obesity-induced vascul...

Diagnostic Performance of Machine Learning Based CT-FFR in Detecting Ischemia in Myocardial Bridging and Concomitant Proximal Atherosclerotic Disease.

The diagnostic performance of coronary computed tomography angiography-derived fractional flow reserve (CT-FFR) in detecting ischemia in myocardial bridging (MB) has not been investigated to date.

A Step Back in the Diagnosis and Management of Myocardial Bridging.

The effects of diltiazem on growth, reproduction, energy reserves, and calcium-dependent physiology in Daphnia magna.

With the growth of both the pharmaceutical industry and the human population and longevity, more drugs are used and processed each day. Inevitably, these pharmaceuticals enter wastewater through human...

Medical and Biotech [MESH] Definitions

A malformation that is characterized by a muscle bridge over a segment of the CORONARY ARTERIES. Systolic contractions of the muscle bridge can lead to narrowing of coronary artery; coronary compression; MYOCARDIAL ISCHEMIA; MYOCARDIAL INFARCTION; and SUDDEN CARDIAC DEATH.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).

MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.

A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction).

More From BioPortfolio on "Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...

Searches Linking to this Trial