Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
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 Blind (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 ]
- Change in SPECT [ Time Frame: 6 months ]
- Change in AP-CCS [ Time Frame: 6 months ]
|Study Start Date:||January 2007|
|Study Completion Date:||November 2012|
|Primary Completion Date:||June 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- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662727
|Hadassah-Hebrew University Medical Center|
|Principal Investigator:||David Leibowitz, MD||Hadassah Medical Organization|