Refractory Angina PectorisPhase 1NCT01219218
Extracorporeal Shockwave Therapy for the Treatment of Advanced 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 Netherlands.
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
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jun 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
- 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).
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study
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 treatment session (9 in total, spread over 9 weeks) 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 |
|---|---|---|
| A | 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 months 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 segment 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 (Exercise Tolerance Test- 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 posted13 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJun 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Academisch Ziekenhuis Maastricht
- Responsible party
- Sponsor
- Investigators
- Prof. Johannes Waltenberger, MD, PhD, Principal investigator, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219218
- Sponsor's protocol ID
- ESMR-AZM-NL
- Status last verified
- Feb 2013
- First submitted
- 10 Oct 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study
- ClinicalTrials.gov ID
- NCT01219218
- Acronym / sponsor ID
- ESMR-AZM-NL
- Conditions
- Refractory Angina Pectoris
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Academisch Ziekenhuis Maastricht
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Oct 2010 (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 treatment session (9 in total, spread over 9 weeks) are required for optimal results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | 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 (9 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
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 | A |
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 months 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Prof. Johannes Waltenberger, MD, PhD principal investigator
Academisch Ziekenhuis Maastricht
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 Netherlands.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 20 Feb 2013. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 20 Feb 2013.