Status:
WITHDRAWN
Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
Lead Sponsor:
Storz Medical AG
Collaborating Sponsors:
Technical University of Munich
Conditions:
Refractory Angina Pectoris
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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 myocar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03438500
Start Date
September 1 2022
End Date
September 1 2022
Last Update
October 31 2022
Active Locations (1)
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1
Technische Universität München I. Medizinische Klinik und Poliklinik
München, Germany, 81675