Clinical Trial: Treatment of Refractory Angina Pectoris by Shock Wave Therapy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris

Brief Summary: The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is safe and effective for the treatment of refractory angina pectoris.

Detailed Summary:

Patients with advanced CAD frequently have limited symptoms with recurrent angina, angina at low work thresholds, breathlessness, and other debilitating conditions. These patients have often been through several "re-do" coronary bypass procedures and multiple percutaneous coronary interventions.

Surgical and interventional options for these patients typically have been exhausted or will result in only partial revascularization. Therefore, therapy remains limited to the use of multiple anti-anginal medications, reduced activity, exertion, and stress level, and significant alteration and limitation of lifestyle.

The goal of this emerging approach is to therapeutically induce the growth and development of new vasculature in zones of severe ischemia in the myocardium, with the hope that new capillaries and arterioles generated will connect to remnant existing vasculature. These neovessels are viewed to act as collaterals, perfusing ischemic territories unapproachable by macro procedures such as PCI and/or CABG.

Sponsor: Universal Research Group

Current Primary Outcome: Alleviation of anginal symptoms [ Time Frame: 06 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Universal Research Group

Dates:
Date Received: October 20, 2008
Date Started: February 2008
Date Completion:
Last Updated: October 20, 2008
Last Verified: October 2008