Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless. At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Energy Density - 0.09 mJ/mm2
Placebo
Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Essen, Germany
Total Exercise Time
The primary efficacy endpoint is the change in maximal stress exercise capacity using the modified Bruce exercise test from baseline to the 6 months post-baseline assessment.
Time frame: 6 months
The incidence of adverse events at 12 months post treatment
Incidence of patient complications, adverse reactions and rise in cardiac enzymes, blood count, platelate count renal and hepatic function, and Troponin levels, as well as E.C.G. changes, 12 months post treatment.
Time frame: 15 months
Change in Seattle Angina Questionnaire (SAQ)
The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely
Time frame: 6 months
Change in AP-CCS
The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
Time frame: 6 months
Change in the Number of angina attacks
The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented.
Time frame: 6 months
Change in the Hospital Admission Rate
The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented.
Time frame: 6 months
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