Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
Recruitment status was: Active, not recruiting
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.
|Refractory Angina Pectoris||Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Device: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241968
|Westdeutsches Herzzentrum ,Universität Duisburg/Essen|
|Principal Investigator:||Alexander Lind, MD||Westdeutsches Herzzentrum ,Universität Duisburg/Essen|