NCT00776568

Treatment of Refractory Angina Pectoris by Shock Wave Therapy

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universal Research Group · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
PROCEDURE	Extra-corporeal shockwave	Low intensity shock waves are applied as 300 shocks per visit for 09 visits. The treatment visit is carried at week 1, 5 and 9.
DRUG	Anti-hypertensive drugs	ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-08-01
• First posted: 2008-10-21
• Last updated: 2008-10-21

Locations

1 site across 1 country: Pakistan