Coronary Artery Disease, Ischemic Heart Disease, Refractory Angina Pectoris
Conditions
Brief summary
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
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.
Interventions
DEVICECardiac Extracorporeal Shockwave Therapy (Modulith SLC)
40 - 60 spots per visit (200 shots/spot) at Energy Level 3
Sponsors
Technical University of Munich
Storz Medical AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of myocardial perfusion reserve (MPR) | 14 weeks | Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diffuse fibrosis | 5 weeks | Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks |
| Enddiastolic volume | 5 weeks | Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks |
| Endsystolic volume | 5 weeks | Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks |
| Stroke volume | 5 weeks | Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks |
| Ejection fraction | 5 weeks | Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks |
| Regional wall motion | 5 weeks | Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks |
| Severity and frequency of angina | 5 weeks | Change from baseline in Seattle Angina questionnaire at 5 weeks |
| New York Heart Association (NYHA) class | 5 weeks | Change from baseline in NYHA class at 5 weeks |
| Exercise capacity | 5 weeks | Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks |
| Quality of life (SF-36) | 5 weeks | Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks |
| New myocardial scarring or fibrotic changes | 5 weeks | Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks |
| Myocardial edema | 5 weeks | Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks |
| Myocardial hemorrhage | 5 weeks | Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks |
| Scar extent | 5 weeks | Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks |
Countries
Germany
Outcome results
None listed