Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241968
Recruitment Status : Unknown
Verified February 2013 by Medispec.
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2010
Last Update Posted : February 20, 2013
Universität Duisburg-Essen
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Refractory Angina Pectoris Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Device: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : June 2009
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Active Comparator: A
A - Treatment group. Patients in this group receive actual shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
Other Names:
  • Cardiospec
  • ESMR therapy
  • Extracorporeal Shockwave Myocardial Revascularization

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

Primary Outcome Measures :
  1. Total Exercise Time [ Time Frame: 6 months ]
    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.

  2. The incidence of adverse events at 12 months post treatment [ Time Frame: 15 months ]
    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.

Secondary Outcome Measures :
  1. Change in Seattle Angina Questionnaire (SAQ) [ Time Frame: 6 months ]
    The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely

  2. Change in AP-CCS [ Time Frame: 6 months ]
    The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.

  3. Change in the Number of angina attacks [ Time Frame: 6 months ]
    The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented.

  4. Change in the Hospital Admission Rate [ Time Frame: 6 months ]
    The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241968

Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Essen, Germany
Sponsors and Collaborators
Universität Duisburg-Essen
Principal Investigator: Alexander Lind, MD Westdeutsches Herzzentrum ,Universität Duisburg/Essen

Responsible Party: Medispec Identifier: NCT01241968     History of Changes
Other Study ID Numbers: ESMR-RCT-DE
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Medispec:
Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms