Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

NCT ID: NCT00662727

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-11-30

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- 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.

Conditions

Refractory Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Intervention Type: DEVICE

Energy Density - 0.09 mJ/mm2

B

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Placebo

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Energy Density - 0.09 mJ/mm2

Intervention Type: DEVICE

Placebo

Placebo

Intervention Type: DEVICE

Other Intervention Names

Cardiospec; ESMR therapy; Extracorporeal Shockwave Myocardial Revascularization

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: collaborator

Medispec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Leibowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah-Hebrew University Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ESMR-RCT-IL

Identifier Type: -

Identifier Source: org_study_id