An interventional study of Cardiac Extracorporeal Shockwave Therapy (Modulith SLC) in Refractory Angina Pectoris, Ischemic Heart Disease and Coronary Artery Disease, sponsored by Storz Medical AG. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by Storz Medical AG · Not applicable, Interventional, and Treatment
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.
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.
453 studies on the registry are indexed under Angina Pectoris; 67 are open to participants now.
Browse Angina Pectoris studies →Storz Medical AG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Modulith SLC, Extracorporeal Cardiac Shockwave Therapy (CSWT)
Change of myocardial perfusion reserve (MPR)
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks
Time frame: 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
Time frame: 5 weeks
Enddiastolic volume
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks
Time frame: 5 weeks
Enddiastolic volume
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks
Time frame: 14 weeks
Endsystolic volume
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks
Time frame: 5 weeks
Endsystolic volume
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks
Time frame: 14 weeks
Stroke volume
Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks
Time frame: 5 weeks
Stroke volume
Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks
Time frame: 14 weeks
Ejection fraction
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks
Time frame: 5 weeks
Ejection fraction
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks
Time frame: 14 weeks
Regional wall motion
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks
Time frame: 5 weeks
Regional wall motion
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks
Time frame: 14 weeks
Scar extent
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks
Time frame: 5 weeks
Scar extent
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks
Time frame: 14 weeks
Diffuse fibrosis
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks
Time frame: 5 weeks
Diffuse fibrosis
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks
Time frame: 14 weeks
Severity and frequency of angina
Change from baseline in Seattle Angina questionnaire at 5 weeks
Time frame: 5 weeks
Severity and frequency of angina
Change from baseline in Seattle Angina questionnaire at 14 weeks
Time frame: 14 weeks
New York Heart Association (NYHA) class
Change from baseline in NYHA class at 5 weeks
Time frame: 5 weeks
New York Heart Association (NYHA) class
Change from baseline in NYHA class at 14 weeks
Time frame: 14 weeks
Exercise capacity
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks
Time frame: 5 weeks
Exercise capacity
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 14 weeks
Myocardial edema
Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks
Time frame: 5 weeks
Myocardial edema
Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks
Time frame: 14 weeks
Myocardial hemorrhage
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks
Time frame: 5 weeks
Myocardial hemorrhage
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks
Time frame: 14 weeks
Plan to share: No
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This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Storz Medical AG