Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris
SuspendedPhase 1NCT01567592
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- Official title
- Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
- Conditions
- Refractory Angina Pectoris
- Interventions
- Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
- Sponsor
- Medispec
- Collaborators
- KMH Cardiology and Diagnostic Centres
- Start date
- 2009-03
- Primary completion
- 2012-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria 1. The patient will have an acoustic window to the myocardium by echocardiography. 4 chamber view (4CH), 2 chamber view (2CH), long axis (LAX) and short axis view (SAX) should be verified. 2. Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT. 3. Patient has documented myocardial reversible ischemia and or hibernation in at least one segment. 4. Patient is classified as AP CCS of III or IV. 5. Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. 6. Patients demonstrates exercise tolerance time (ETT) duration \< 10 minutes on a modified Bruce protocol on 2 consecutive tests (tests no less than 24 hours and no more than 2 weeks apart), with the second test within the difference of 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study). 7. Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization. 8. Patient has refused to undergo another angioplasty or CABG. 9. Patient has signed an informed consent form. 10. Patient's condition should be stable and should have a life expectancy of \> 12 months. 11. 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 1. Patient has chronic lung disease based on the GOLD criteria the patient has stage IV: Very Severe COPD according to Spirometric Classification of COPD, Severity based on Post-Bronchodilator 2. Patient has emphysema and pulmonary fibrosis. 3. Patient has active endocarditis, myocarditis or pericarditis. 4. 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 was treated with TMR (Transmyocardial revascularization) or PMR (Percutaneous revascularization) , or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study. 5. Patients who are unwilling or unable to cooperate with study procedure. 6. Patients who are unwilling to quit smoking during the study procedure (including screening phase) 7. Patients who…
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| KMH Cardiology & Diagnostic Centers | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01567592