Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Not Applicable

Withdrawn

• Conditions: Ischemic Heart Disease; Refractory Angina Pectoris; Coronary Artery Disease
• Interventions: Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

• Registration Number: NCT03438500
• Lead Sponsor: Storz Medical AG

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.

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Study Start: 2022-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Shockwave Therapy	Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)	Patients in this group receive shockwave therapy.

Primary Outcome Measures

Name	Time	Method
Change of myocardial perfusion reserve (MPR)	5 weeks	Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks

Secondary Outcome Measures

Name	Time	Method
Regional wall motion	14 weeks	Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks
Enddiastolic volume	14 weeks	Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks
Endsystolic volume	14 weeks	Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks
Stroke volume	14 weeks	Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks
Ejection fraction	14 weeks	Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks
Severity and frequency of angina	14 weeks	Change from baseline in Seattle Angina questionnaire at 14 weeks
New York Heart Association (NYHA) class	14 weeks	Change from baseline in NYHA class at 14 weeks
Exercise capacity	14 weeks	Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks
Quality of life (SF-36)	14 weeks	Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks
New myocardial scarring or fibrotic changes	14 weeks	Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks
Myocardial edema	14 weeks	Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks
Myocardial hemorrhage	14 weeks	Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks
Scar extent	14 weeks	Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks
Diffuse fibrosis	14 weeks	Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks

Trial Locations

Locations (1)

Technische Universität München I. Medizinische Klinik und Poliklinik; 🇩🇪 München, Germany