Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris
- Conditions
- Refractory Angina Pectoris
- Interventions
- Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
- Registration Number
- NCT01567592
- 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
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Shockwave Therapy Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Treatment group. Patients in this group receive actual shockwave therapy.
- Primary Outcome Measures
Name Time Method Time to Angina 6 months Change in time to angina using the modified Bruce exercise test from baseline to the 6 moths post baseline assessment
- Secondary Outcome Measures
Name Time Method Number of angina attacks (patient diary) 6 months The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.
Change in SPECT 6 months The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segments model).
Change in AP-CCS 6 months The AP CCS Stage at the 6 months post baseline.
Total Exercise time 6 months The change in Total Exercise Time (ETT) from baseline to 6 months post baseline.
Trial Locations
- Locations (1)
KMH Cardiology & Diagnostic Centers
🇨🇦Ontario, Canada