Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

Refractory Angina Pectoris Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01241968
• Other study ID #: ESMR-RCT-DE
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 15, 2010
• Last updated: February 17, 2013
• Start date: June 2009
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina Pectoris

Intervention

Device:
• Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Westdeutsches Herzzentrum ,Universität Duisburg/Essen	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Exercise Time	The primary efficacy endpoint is the change in maximal stress exercise capacity using the modified Bruce exercise test from baseline to the 6 months post-baseline assessment.	6 months	No
Primary	The incidence of adverse events at 12 months post treatment	Incidence of patient complications, adverse reactions and rise in cardiac enzymes, blood count, platelate count renal and hepatic function, and Troponin levels, as well as E.C.G. changes, 12 months post treatment.	15 months	Yes
Secondary	Change in Seattle Angina Questionnaire (SAQ)	The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely	6 months	No
Secondary	Change in AP-CCS	The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.	6 months	No
Secondary	Change in the Number of angina attacks	The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented.	6 months	No
Secondary	Change in the Hospital Admission Rate	The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented.	6 months	No