Clinical trial NCT01241968: Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
Official title: Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Refractory Angina Pectoris
Keywords: Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Universität Duisburg-Essen
First posted: 2010-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Total Exercise Time
timeFrame: 6 months
measure: The incidence of adverse events at 12 months post treatment
timeFrame: 15 months
Secondary outcomes:
measure: Change in Seattle Angina Questionnaire (SAQ)
timeFrame: 6 months
measure: Change in AP-CCS
timeFrame: 6 months
measure: Change in the Number of angina attacks
timeFrame: 6 months
measure: Change in the Hospital Admission Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Study officials:
affiliation: Westdeutsches Herzzentrum ,Universität Duisburg/Essen
name: Alexander Lind, MD
role: PRINCIPAL_INVESTIGATOR
References: