Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

NCT ID: NCT01241968

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-04-30

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-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.

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

• 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

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

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

Medispec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Lind, MD

Role: PRINCIPAL_INVESTIGATOR

Westdeutsches Herzzentrum ,Universität Duisburg/Essen

Locations

Westdeutsches Herzzentrum ,Universität Duisburg/Essen

Essen, , Germany

Countries

Germany

Other Identifiers

ESMR-RCT-DE

Identifier Type: -

Identifier Source: org_study_id