Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Study Overview
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Brief Summary
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The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

Detailed Description
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This is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries. A total of 10 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post CSWT procedure.

Official Title
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The Impact of Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve in the Absence of Epicardial Coronary Artery Stenoses: A Pilot Study

Conditions
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Refractory Angina Pectoris, Ischemic Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion CMR) Evidence for stress-induced myocardial ischemia in this examination Coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries Exclusion Criteria: Participation in other clinical trials age <18 years Contraindications to under cMRI Contraindications to adenosine (severe chronic obstructive pulmonary disease (COPD), asthma, atrioventricular block (AV block) > grade 1) Left ventricular thrombus Uncontrolled diabetes mellitus Uncontrolled arterial hypertension, Any other severe chronic illness such as liver or renal failure (glomerular filtration rate (GFR) < 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months Patients with pacemaker or implanted cardioverter defibrillator Patients after valve surgical replacement Patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or MitraClip implantation) Pregnancy (a reliable method of contraception must be used for the entire duration of the study) Fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country Missing capacity to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Shockwave Therapy<br>Patients in this group receive shockwave therapy. | Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)<br>* 40 - 60 spots per visit (200 shots/spot) at Energy Level 3<br>* Other names: Extracorporeal Cardiac Shockwave Therapy (CSWT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of myocardial perfusion reserve (MPR) | Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks | 14 weeks | 
| Change of myocardial perfusion reserve (MPR) | Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enddiastolic volume | Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks | 5 weeks | 
| Enddiastolic volume | Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks | 14 weeks | 
| Endsystolic volume | Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks | 5 weeks | 
| Endsystolic volume | Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks | 14 weeks | 
| Stroke volume | Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks | 5 weeks | 
| Stroke volume | Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks | 14 weeks | 
| Ejection fraction | Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks | 5 weeks | 
| Ejection fraction | Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks | 14 weeks | 
| Regional wall motion | Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks | 5 weeks | 
| Regional wall motion | Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks | 14 weeks | 
| Scar extent | Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks | 5 weeks | 
| Scar extent | Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks | 14 weeks | 
| Diffuse fibrosis | Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks | 5 weeks | 
| Diffuse fibrosis | Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks | 14 weeks | 
| Severity and frequency of angina | Change from baseline in Seattle Angina questionnaire at 5 weeks | 5 weeks | 
| Severity and frequency of angina | Change from baseline in Seattle Angina questionnaire at 14 weeks | 14 weeks | 
| New York Heart Association (NYHA) class | Change from baseline in NYHA class at 5 weeks | 5 weeks | 
| New York Heart Association (NYHA) class | Change from baseline in NYHA class at 14 weeks | 14 weeks | 
| Exercise capacity | Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks | 5 weeks | 
| Exercise capacity | Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks | 14 weeks | 
| Quality of life (SF-36) | Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks | 5 weeks | 
| Quality of life (SF-36) | Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks | 14 weeks | 
| New myocardial scarring or fibrotic changes | Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks | 5 weeks | 
| New myocardial scarring or fibrotic changes | Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks | 14 weeks | 
| Myocardial edema | Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks | 5 weeks | 
| Myocardial edema | Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks | 14 weeks | 
| Myocardial hemorrhage | Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks | 5 weeks | 
| Myocardial hemorrhage | Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks | 14 weeks |