Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01567644|
Recruitment Status : Unknown
Verified April 2012 by Medispec.
Recruitment status was: Active, not recruiting
First Posted : March 30, 2012
Last Update Posted : April 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory Angina Pectoris||Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)||Phase 1|
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- PET 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||September 2012|
Experimental: Active Shockwave Therapy
Patients in this group receive shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
- Change in AP-CCS [ Time Frame: 6 Months ]The AP CCS Stage at the 6 months post baseline.
- Exercise tolerance time [ Time Frame: 6 Months ]The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
- Change in PET scan [ Time Frame: 6 months ]The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567644
|Heart and Diabetes Center North-Rhine Westfalia|
|Bad Oeynhausen, Germany|
|Principal Investigator:||Lothar Faber, Prof. MD||Heart and Diabetes Center North-Rhine Westfalia|