Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Refractory Angina Pectoris
• Intervention / Treatment: Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 81675
    • Technische Universität München I. Medizinische Klinik und Poliklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active Shockwave Therapy; Patients in this group receive shockwave therapy.	Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC); 40 - 60 spots per visit (200 shots/spot) at Energy Level 3; Other Names: Modulith SLC; Extracorporeal Cardiac Shockwave Therapy (CSWT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Storz Medical AG
• Collaborators: Technical University of Munich
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Angina Pectoris
• Other Study ID Numbers: CSW-1814-SCH-0010-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No