Clinical Trial: Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwav
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 Summary:
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.
Sponsor: Medispec
Current Primary Outcome: Total Exercise Time [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in SPECT [ Time Frame: 6 months ]
- Change in AP-CCS [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Medispec
Dates:
Date Received: April 14, 2008
Date Started: January 2007
Date Completion:
Last Updated: February 17, 2013
Last Verified: February 2013
