Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Storz Medical AG

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Refractory Angina Pectoris Ischemic Heart Disease Coronary Artery Disease

Interventions

Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)DEVICE

40 - 60 spots per visit (200 shots/spot) at Energy Level 3

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Technische Universität München I. Medizinische Klinik und Poliklinik

München, Germany

Outcomes

Primary Outcomes

Change of myocardial perfusion reserve (MPR)

Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks

Time frame: 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

Time frame: 5 weeks

Secondary Outcomes

Enddiastolic volume

Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks

Time frame: 5 weeks

Enddiastolic volume

Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks

Time frame: 14 weeks

Endsystolic volume

Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks

Time frame: 5 weeks

Endsystolic volume

Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks

Time frame: 14 weeks

Stroke volume

Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks

Time frame: 5 weeks

Stroke volume

Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks

Time frame: 14 weeks

Data from ClinicalTrials.gov

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Ejection fraction

Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks

Time frame: 5 weeks

Ejection fraction

Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks

Time frame: 14 weeks

Regional wall motion

Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks

Time frame: 5 weeks

Regional wall motion

Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks

Time frame: 14 weeks

Scar extent

Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks

Time frame: 5 weeks

Scar extent

Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks

Time frame: 14 weeks

Diffuse fibrosis

Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks

Time frame: 5 weeks

Diffuse fibrosis

Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks

Time frame: 14 weeks

Severity and frequency of angina

Change from baseline in Seattle Angina questionnaire at 5 weeks

Time frame: 5 weeks

Severity and frequency of angina

Change from baseline in Seattle Angina questionnaire at 14 weeks

Time frame: 14 weeks

New York Heart Association (NYHA) class

Change from baseline in NYHA class at 5 weeks

Time frame: 5 weeks

New York Heart Association (NYHA) class

Change from baseline in NYHA class at 14 weeks

Time frame: 14 weeks

Exercise capacity

Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks

Time frame: 5 weeks

Exercise capacity

Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 14 weeks

Myocardial edema

Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks

Time frame: 5 weeks

Myocardial edema

Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks

Time frame: 14 weeks

Myocardial hemorrhage

Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks

Time frame: 5 weeks

Myocardial hemorrhage

Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks

Time frame: 14 weeks