A Phase 3 interventional study of Active treatment group and Placebo group in Stable Angina Pectoris, sponsored by Evgeny Shkolnik, MD. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Evgeny Shkolnik, MD · Phase 3, Interventional, and Treatment
Low intensity shockwaves have been proven in animal and pilot clinical studies to induce local growth of new blood vessels. Small single-center clinical trials with shockwave therapy showed promising results in reducing angina symptoms, improving perfusion and contractility in patients with refractory angina and stress-induced ischemia on imaging test.
The hypothesis of this study is that shockwave therapy could improve angina symptoms and exercise tolerance in broader population of patients with stable angina regardless of imaging test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in patients with stable angina.
Low intensity shockwaves (0.09 millijoule/mm2) are delivered to myocardial 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 (ECG) to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes modified Bruce treadmill test, to assess exercise induced ischemia.
Exercise induced ECG ischemia is defined as the new development of horizontal or down - sloping ST segment depression (≥1 mm at 60 ms after J point) versus baseline tracing.
Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session.
During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
The spots are localized by the ultra-sound device and the shockwaves are focused to this area. Several treatments are required for optimal results.
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's enrollment of 72 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →This is the only study on the registry with Evgeny Shkolnik, MD as lead sponsor.
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Exclusion Criteria:
Patients in this group receive actual shockwave therapy. Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session. During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
Device: Active treatment group
This group of patients undergoes the same procedure as the treatment group; however shockwaves are not delivered to the heart.
Device: Placebo group
Energy Density - 0.09 mJ/mm2 Device: Active Applicator
Also known as: Cardiospec, Extracorporeal Shockwave Myocardial Revascularization (ESMR), Extracorporeal Cardiac Shock wave therapy (CSWT)
Placebo Applicator
Change in Total Exercise duration
To evaluate if ESMR able to improve total exercise duration in modified Bruce treadmill test. Patients will be assessed at baseline visit (screening) and 6 months after the first treatment.
Time frame: 6 months
Time to 1 mm ST-segment depression in modified Bruce treadmill test
Time frame: 6 months
Time to angina in modified Bruce treadmill test
Time frame: 6 months
Number of angina attacks per week
Time frame: 6 months
Number of sublingual nitroglycerin consumption per week
Time frame: 6 months
CCS angina functional class
Time frame: 6 months
Seattle angina questionnaire score
Time frame: 6 months
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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