Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Medispec

Status and phase: Completed; Phase 2

Conditions: Refractory Angina Pectoris

Treatments: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec); Device: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00662727

ESMR-RCT-IL

Details and patient eligibility

About

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.

Full 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- 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

A - Treatment group. Patients in this group receive actual shockwave therapy.

Treatment:

Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

B

Placebo Comparator group

Description:

Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.

Treatment:

Device: Placebo