Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03438500
• Other study ID #: CSW-1814-SCH-0010-S
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2022
• Source: Storz Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Refractory Angina Pectoris

Intervention

Device:
• Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
40 - 60 spots per visit (200 shots/spot) at Energy Level 3

Locations

Country	Name	City	State
Germany	Technische Universität München I. Medizinische Klinik und Poliklinik	München

Sponsors (2)

Lead Sponsor	Collaborator
Storz Medical AG	Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Enddiastolic volume	Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks	5 weeks
Secondary	Enddiastolic volume	Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks	14 weeks
Secondary	Endsystolic volume	Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks	5 weeks
Secondary	Endsystolic volume	Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks	14 weeks
Secondary	Stroke volume	Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks	5 weeks
Secondary	Stroke volume	Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks	14 weeks
Secondary	Ejection fraction	Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks	5 weeks
Secondary	Ejection fraction	Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks	14 weeks
Secondary	Regional wall motion	Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks	5 weeks
Secondary	Regional wall motion	Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks	14 weeks
Secondary	Scar extent	Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks	5 weeks
Secondary	Scar extent	Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks	14 weeks
Secondary	Diffuse fibrosis	Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks	5 weeks
Secondary	Diffuse fibrosis	Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks	14 weeks
Secondary	Severity and frequency of angina	Change from baseline in Seattle Angina questionnaire at 5 weeks	5 weeks
Secondary	Severity and frequency of angina	Change from baseline in Seattle Angina questionnaire at 14 weeks	14 weeks
Secondary	New York Heart Association (NYHA) class	Change from baseline in NYHA class at 5 weeks	5 weeks
Secondary	New York Heart Association (NYHA) class	Change from baseline in NYHA class at 14 weeks	14 weeks
Secondary	Exercise capacity	Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks	5 weeks
Secondary	Exercise capacity	Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks	14 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Myocardial edema	Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks	5 weeks
Secondary	Myocardial edema	Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks	14 weeks
Secondary	Myocardial hemorrhage	Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks	5 weeks
Secondary	Myocardial hemorrhage	Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks	14 weeks