Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
- Conditions
- Refractory Angina Pectoris
- Interventions
- Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)Device: Placebo
- Registration Number
- NCT00662727
- Lead Sponsor
- Medispec
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time < 10 min (modified Bruce)
- Two ETT tests results (within two weeks) averaging no more than 25% of their mean
- Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Signed an IRB approved informed consent form.
- Life expectancy of >12 months.
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less <3 months prior to treatment
- Severe Valvular disease
- Child bearing potential
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) A - Treatment group. Patients in this group receive actual shockwave therapy. B Placebo Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
- Primary Outcome Measures
Name Time Method Total Exercise Time 6 months
- Secondary Outcome Measures
Name Time Method Change in SPECT 6 months Change in AP-CCS 6 months
Trial Locations
- Locations (1)
Hadassah-Hebrew University Medical Center
🇮🇱Jerusalem, Israel