Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04130438
Status:
SUSPENDED
Last Update Posted:
2023-11-29
First Post:
2019-04-01
Brief Title:
Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment modifying study protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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 111
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
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 111
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None