Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
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|ClinicalTrials.gov Identifier: NCT01241968|
Recruitment Status : Unknown
Verified February 2013 by Medispec.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2010
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory Angina Pectoris||Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Device: Placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||April 2013|
Active Comparator: A
A - Treatment group. Patients in this group receive actual shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
Placebo Comparator: B
Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
- Total Exercise Time [ Time Frame: 6 months ]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.
- The incidence of adverse events at 12 months post treatment [ Time Frame: 15 months ]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.
- Change in Seattle Angina Questionnaire (SAQ) [ Time Frame: 6 months ]The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely
- Change in AP-CCS [ Time Frame: 6 months ]The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
- Change in the Number of angina attacks [ Time Frame: 6 months ]The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented.
- Change in the Hospital Admission Rate [ Time Frame: 6 months ]The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241968
|Westdeutsches Herzzentrum ,Universität Duisburg/Essen|
|Principal Investigator:||Alexander Lind, MD||Westdeutsches Herzzentrum ,Universität Duisburg/Essen|