Status:
UNKNOWN
Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
Lead Sponsor:
Medispec
Collaborating Sponsors:
Universität Duisburg-Essen
Conditions:
Refractory Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sy...
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 dev...
Eligibility Criteria
Inclusion
- Patient is diagnosed with chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation.
- Patient has documented myocardial segments with reversible ischemia.
- Patient is classified in AP CCS of III-IV.
- Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
- Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
- Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Patient has signed an IRB approved informed consent form.
- Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.
Exclusion
- Patient is pregnant
- Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- Patient has active endocarditis, myocarditis or pericarditis.
- Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
- Patients who are unwilling or unable to cooperate with study procedure
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01241968
Start Date
June 1 2009
End Date
April 1 2013
Last Update
February 20 2013
Active Locations (1)
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1
Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Essen, Germany