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Sponsor & PI decision
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Shockwave Therapy | Experimental | Patients in this group receive shockwave therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Extracorporeal Shockwave Therapy (Modulith SLC) | Device | 40 - 60 spots per visit (200 shots/spot) at Energy Level 3 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Schmidt, Prof. Dr. | Technische Universität München I. Medizinische Klinik und Poliklinik | Principal Investigator |
| Alexander Steger, Dr. med. | Technische Universität München I. Medizinische Klinik und Poliklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität München I. Medizinische Klinik und Poliklinik | München | 81675 | Germany |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| 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 |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |