Back to resultsExtracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris
Primary Purpose
Refractory Angina Pectoris
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
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, for a period of at least 3 months. 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
- Academisch Ziekenhuis Maastricht
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Treatment group. Patients in this group receive actual shockwave therapy.
Outcomes
Primary Outcome Measures
Time to Angina
Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment
Secondary Outcome Measures
Change in SPECT
The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segment model)
Change in AP-CCS
The AP-CCS stage at the 6 months post baseline.
Total Exercise time
The change in total exercise time (Exercise Tolerance Test- ETT) from baseline to 6 months post baseline.
Number of Angina attacks (patient diary)
The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.
Full Information
NCT ID
NCT01219218
First Posted
October 10, 2010
Last Updated
February 17, 2013
Sponsor
Medispec
Collaborators
Academisch Ziekenhuis Maastricht
1. Study Identification
Unique Protocol Identification Number
NCT01219218
Brief Title
Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris
Official Title
Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medispec
Collaborators
Academisch Ziekenhuis Maastricht
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-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 treatment session (9 in total, spread over 9 weeks) 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 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Treatment group. Patients in this group receive actual shockwave therapy.
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
Primary Outcome Measure Information:
Title
Time to Angina
Description
Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in SPECT
Description
The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segment model)
Time Frame
6 months
Title
Change in AP-CCS
Description
The AP-CCS stage at the 6 months post baseline.
Time Frame
6 months
Title
Total Exercise time
Description
The change in total exercise time (Exercise Tolerance Test- ETT) from baseline to 6 months post baseline.
Time Frame
6 months
Title
Number of Angina attacks (patient diary)
Description
The change in the number of angina attacks from baseline to 6 months post baseline. 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, for a period of at least 3 months. 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
Prof. Johannes Waltenberger, MD, PhD
Organizational Affiliation
Academisch Ziekenhuis Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris
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