Back to resultsExtracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
Primary Purpose
Refractory Angina Pectoris
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Angina Pectoris focused on measuring Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
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
Sites / Locations
- Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
A - Treatment group. Patients in this group receive actual shockwave therapy.
Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Change in AP-CCS
The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
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.
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.
Full Information
NCT ID
NCT01241968
First Posted
November 15, 2010
Last Updated
February 17, 2013
Sponsor
Medispec
Collaborators
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT01241968
Brief Title
Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medispec
Collaborators
Universität Duisburg-Essen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina Pectoris
Keywords
Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
A - Treatment group. Patients in this group receive actual shockwave therapy.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
Intervention Type
Device
Intervention Name(s)
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Other Intervention Name(s)
Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization
Intervention Description
Energy Density - 0.09 mJ/mm2
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Total Exercise Time
Description
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.
Time Frame
6 months
Title
The incidence of adverse events at 12 months post treatment
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Change in Seattle Angina Questionnaire (SAQ)
Description
The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely
Time Frame
6 months
Title
Change in AP-CCS
Description
The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
Time Frame
6 months
Title
Change in the Number of angina attacks
Description
The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented.
Time Frame
6 months
Title
Change in the Hospital Admission Rate
Description
The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Lind, MD
Organizational Affiliation
Westdeutsches Herzzentrum ,Universität Duisburg/Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westdeutsches Herzzentrum ,Universität Duisburg/Essen
City
Essen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
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