Refractory Angina PectorisPhase 1NCT01567592
Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris
A Phase 1 study testing Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) in people with Refractory Angina Pectoris, run by Medispec at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina Pectoris
- What is being tested?
- Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT.
- Patient has documented myocardial reversible ischemia and or hibernation in at least one segment.
- Patient is classified as AP CCS of III or IV.
- Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- 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).
Show all 11Show fewer
- Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
- Patient has refused to undergo another angioplasty or CABG.
- Patient has signed an 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.
Who cannot join
- 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
- Patient has 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 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.
- Patients who are unwilling or unable to cooperate with study procedure.
- Patients who are unwilling to quit smoking during the study procedure (including screening phase)
Show all 16Show fewer
- Patients who had MI less than 3 months prior to treatment
- Patients with moderately severe or severe valvular disease. Moderately-severe and severe disease will be echographically diagnosed as follows:
- Aortic Stenosis: Patients with Moderately-severe [Peak Aortic valve gradient (AVG): 50-60 mmHg; Mean AVG: 30-40 mmHg; Effective orifice area (EOA): 0.75-1.0 cm2] and severe Aortic Stenosis [Peak AVG: above 60 mmHg; Mean AVG: above 40 mmHg; EOA: below 0.75 cm2]
- Mitral Stenosis: Patients with severe Mitral Stenosis [EOA: below 1 cm2; Pressure half-time (ms): above 200 mmHg; Mean Mitral valve gradient: above 10 mmHg]
- Aortic Regurgitation \& Mitral Regurgitation: Patients with moderately- severe and severe aortic regurgitation and mitral regurgitation will be excluded.
- Moderately-severe (grade 3, or 3/4) and severe (grade 4, or 4/4) are hemodynamically significant.
- Tricuspid Regurgitation (TR): Its severity is graded from 1-4 as for aortic and mitral regurgitation. Grades 3 and 4 will be excluded from the study. The more severe levels of TR are common in severe biventricular failure, mitral stenosis, cor pulmunale and any other cause of pulmonary hypertension.
- Patient with intraventricular thrombus
- Patient is pregnant
- Patient with a malignancy in the area of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
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.
Read the 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 treatments are required for optimal results.
- Conditions
- Refractory Angina Pectoris
- Being tested
- Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Medical subject headings
- Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)Device
Also called Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization
Energy Density - 0.09 mJ/mm2
| Study group | Role | What they receive |
|---|---|---|
| Active Shockwave Therapy | Experimental | Treatment group. Patients in this group receive actual shockwave therapy. Receives: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Angina
Change in time to angina using the modified Bruce exercise test from baseline to the 6 moths post baseline assessment
Measured: 6 months
Secondary outcomes (4)
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 segments model).
Measured: 6 months
Change in AP-CCS
The AP CCS Stage at the 6 months post baseline.
Measured: 6 months
Total Exercise time
The change in Total Exercise Time (ETT) from baseline to 6 months post baseline.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KMH Cardiology and Diagnostic Centres
- Responsible party
- Sponsor
- Investigators
- Arvi Grover, MD, Principal investigator, KMH Cardiology & Diagnostic Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567592
- Sponsor's protocol ID
- ESMR-KMH-Canada
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
- ClinicalTrials.gov ID
- NCT01567592
- Acronym / sponsor ID
- ESMR-KMH-Canada
- Conditions
- Refractory Angina Pectoris
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- KMH Cardiology and Diagnostic Centres
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatments are required for optimal results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Shockwave Therapy | Experimental | Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)Treatment group. Patients in this group receive actual shockwave therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT.
- Patient has documented myocardial reversible ischemia and or hibernation in at least one segment.
- Patient is classified as AP CCS of III or IV.
- Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
Key exclusion criteria (16 listed)
- 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
- Patient has 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 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.
- Patients who are unwilling or unable to cooperate with study procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)Also: Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial RevascularizationEnergy Density - 0.09 mJ/mm2 | Device | Active Shockwave Therapy |
Primary outcome
Time to Angina
Time frame: 6 months
Change in time to angina using the modified Bruce exercise test from baseline to the 6 moths post baseline assessment
4 secondary outcomes
Change in SPECT
Time frame: 6 months
Change in AP-CCS
Time frame: 6 months
Total Exercise time
Time frame: 6 months
Number of angina attacks (patient diary)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
Related trials for Refractory Angina Pectoris
Recruiting
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Refractory Angina
RecruitingPhase 2
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
Refractory Angina, Coronary Artery Disease
Active, not recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Refractory Angina, Microvascular Angina
RecruitingPhase 2
Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
Refractory Angina Pectoris, Refractory Angina
Active, not recruiting
CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
Refractory Angina, Chronic Myocardial Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvi Grover, MD principal investigator
KMH Cardiology & Diagnostic Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) in people with Refractory Angina Pectoris, run by Medispec at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Angina (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.