Clinical Trial: Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

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: Time to Angina [ Time Frame: 6 months ]

Change in time to angina using the modified Bruce exercise test from baseline to the 6 moths post baseline assessment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in SPECT [ Time Frame: 6 months ]
    The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segments model).
  • Change in AP-CCS [ Time Frame: 6 months ]
    The AP CCS Stage at the 6 months post baseline.
  • Total Exercise time [ Time Frame: 6 months ]
    The change in Total Exercise Time (ETT) from baseline to 6 months post baseline.
  • Number of angina attacks (patient diary) [ Time Frame: 6 months ]
    The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.


Original Secondary Outcome: Same as current

Information By: Medispec

Dates:
Date Received: March 28, 2012
Date Started: March 2009
Date Completion: December 2012
Last Updated: April 1, 2012
Last Verified: April 2012