NCT01241968

Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medispec · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.

Conditions

• Refractory Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)	Energy Density - 0.09 mJ/mm2
DEVICE	Placebo	Placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-08-01
• Completion: 2013-04-01
• First posted: 2010-11-16
• Last updated: 2013-02-20

Locations

1 site across 1 country: Germany