Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
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)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device|
- Change in AP-CCS [ Time Frame: 6 Months ]The AP CCS Stage at the 6 months post baseline.
- Exercise tolerance time [ Time Frame: 6 Months ]The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
- Change in PET scan [ Time Frame: 6 months ]The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Active Shockwave Therapy
Patients in this group receive shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
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- PET 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: NCT01567644
|Heart and Diabetes Center North-Rhine Westfalia|
|Bad Oeynhausen, Germany|
|Principal Investigator:||Lothar Faber, Prof. MD||Heart and Diabetes Center North-Rhine Westfalia|