Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Conditions
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Refractory Angina Pectoris

Intervention / Treatment
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* Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with chronic stable angina pectoris. Documented myocardial segments with reversible ischemia AP CCS class of III-IV. Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. Exercise tolerance time < 10 min (modified Bruce) Two ETT tests results (within two weeks) averaging no more than 25% of their mean Documented epicardial coronary artery disease not amenable to angioplasty or CABG. Signed an IRB approved informed consent form. Life expectancy of >12 months. Exclusion Criteria: Intraventricular thrombus Malignancy in the area of treatment Severe COPD No smoking during the study procedure MI less <3 months prior to treatment Severe Valvular disease Child bearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>A - Treatment group. Patients in this group receive actual shockwave therapy. | Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)<br>* Energy Density - 0.09 mJ/mm2<br>* Other names: Extracorporeal Shockwave Myocardial Revascularization;|
| Placebo Comparator: B<br>Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart. | Device: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Exercise Time |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SPECT |  | 6 months | 
| Change in AP-CCS |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina