Clinical trial NCT03438500: Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Refractory Angina Pectoris
Ischemic Heart Disease
Coronary Artery Disease
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
Collaborators: name: Technical University of Munich
First posted: 2018-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of myocardial perfusion reserve (MPR)
timeFrame: 14 weeks
measure: Change of myocardial perfusion reserve (MPR)
timeFrame: 5 weeks
Secondary outcomes:
measure: Enddiastolic volume
timeFrame: 5 weeks
measure: Enddiastolic volume
timeFrame: 14 weeks
measure: Endsystolic volume
timeFrame: 5 weeks
measure: Endsystolic volume
timeFrame: 14 weeks
measure: Stroke volume
timeFrame: 5 weeks
measure: Stroke volume
timeFrame: 14 weeks
measure: Ejection fraction
timeFrame: 5 weeks
measure: Ejection fraction
timeFrame: 14 weeks
measure: Regional wall motion
timeFrame: 5 weeks
measure: Regional wall motion
timeFrame: 14 weeks
measure: Scar extent
timeFrame: 5 weeks
measure: Scar extent
timeFrame: 14 weeks
measure: Diffuse fibrosis
timeFrame: 5 weeks
measure: Diffuse fibrosis
timeFrame: 14 weeks
measure: Severity and frequency of angina
timeFrame: 5 weeks
measure: Severity and frequency of angina
timeFrame: 14 weeks
measure: New York Heart Association (NYHA) class
timeFrame: 5 weeks
measure: New York Heart Association (NYHA) class
timeFrame: 14 weeks
measure: Exercise capacity
timeFrame: 5 weeks
measure: Exercise capacity
timeFrame: 14 weeks
measure: Quality of life (SF-36)
timeFrame: 5 weeks
measure: Quality of life (SF-36)
timeFrame: 14 weeks
measure: New myocardial scarring or fibrotic changes
timeFrame: 5 weeks
measure: New myocardial scarring or fibrotic changes
timeFrame: 14 weeks
measure: Myocardial edema
timeFrame: 5 weeks
measure: Myocardial edema
timeFrame: 14 weeks
measure: Myocardial hemorrhage
timeFrame: 5 weeks
measure: Myocardial hemorrhage
timeFrame: 14 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: Technische Universität München I. Medizinische Klinik und Poliklinik
Study officials:
affiliation: Technische Universität München I. Medizinische Klinik und Poliklinik
name: Georg Schmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universität München I. Medizinische Klinik und Poliklinik
name: Alexander Steger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: