Refractory Angina PectorisPhase 2NCT01241968
Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease
A Phase 2 study testing Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) in people with Refractory Angina Pectoris, run by Medispec at 1 site in Germany.
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?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Apr 2013
- Phase
- Phase 2
- 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. 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).
Show all 9Show fewer
- 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: Randomized, Placebo Controlled, Double Blind 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-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.
- Conditions
- Refractory Angina Pectoris
- Being tested
- Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec), Placebo
- 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
PlaceboDevice
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A - Treatment group. Patients in this group receive actual shockwave therapy. Receives: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) |
| B | Placebo comparator | Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 15 months
Secondary outcomes (4)
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
Measured: 6 months
Change in AP-CCS
The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
Measured: 6 months
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.
Measured: 6 months
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.
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 posted16 Nov 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionApr 2013 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universität Duisburg-Essen
- Responsible party
- Sponsor
- Investigators
- Alexander Lind, MD, Principal investigator, Westdeutsches Herzzentrum ,Universität Duisburg/Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241968
- Sponsor's protocol ID
- ESMR-RCT-DE
- Status last verified
- Feb 2013
- First submitted
- 15 Nov 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
- Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
- ClinicalTrials.gov ID
- NCT01241968
- Acronym / sponsor ID
- ESMR-RCT-DE
- Conditions
- Refractory Angina Pectoris
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Universität Duisburg-Essen
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Apr 2013 (estimated)
- First posted
- 16 Nov 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-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)A - Treatment group. Patients in this group receive actual shockwave therapy. |
| B | Placebo comparator | Device: PlaceboPlacebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart. |
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. 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 |
| PlaceboPlacebo | Device | B |
Primary outcome
Total Exercise Time
Time frame: 6 months
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
Time frame: 15 months
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.
4 secondary outcomes
Change in Seattle Angina Questionnaire (SAQ)
Time frame: 6 months
Change in AP-CCS
Time frame: 6 months
Change in the Number of angina attacks
Time frame: 6 months
Change in the Hospital Admission Rate
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 20 Feb 2013.
Related trials for Refractory Angina Pectoris
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
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
Not yet recruiting
Coronary Sinus Reducer Therapy for Persisting Angina
Coronary Artery Disease, Angina (Stable)
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.
Alexander Lind, MD principal investigator
Westdeutsches Herzzentrum ,Universität Duisburg/Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) in people with Refractory Angina Pectoris, run by Medispec at 1 site in Germany.
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: status not confirmed, 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 Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total Exercise Time (time frame: 6 months). The study lists 2 primary outcomes in all. 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.