Refractory Angina PectorisPhase 1NCT01567644
Extracorporeal Shockwave Therapy for the Treatment of Refractory 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 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?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Sep 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
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time < 10 min (modified Bruce)
- Two ETT tests results (within two weeks) averaging no more than 25% of their mean
Show all 9Show fewer
- Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Signed an IRB approved informed consent form.
- Life expectancy of > 12 months.
Who cannot join
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less < 3 months prior to treatment
- Severe Valvular disease
- Child bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic 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- PET 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 | Patients in this group receive 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.
Change in AP-CCS
The AP CCS Stage at the 6 months post baseline.
Measured: 6 Months
Secondary outcomes (2)
Exercise tolerance time
The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
Measured: 6 Months
Change in PET scan
The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.
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 startJan 2008
- Primary completionApr 2012 (estimated)
- Study completionSep 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heart and Diabetes Center North-Rhine Westfalia
- Responsible party
- Sponsor
- Investigators
- Lothar Faber, Prof. MD, Principal investigator, Heart and Diabetes Center North-Rhine Westfalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567644
- Sponsor's protocol ID
- ESMR-NRW-DE
- Status last verified
- Apr 2012
- First submitted
- 15 Nov 2010
- 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 Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
- ClinicalTrials.gov ID
- NCT01567644
- Acronym / sponsor ID
- ESMR-NRW-DE
- Conditions
- Refractory Angina Pectoris
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Heart and Diabetes Center North-Rhine Westfalia
- Study start
- Jan 2008
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Sep 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- PET 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)Patients in this group receive 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)
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time < 10 min (modified Bruce)
Key exclusion criteria (7 listed)
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less < 3 months prior to treatment
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
Change in AP-CCS
Time frame: 6 Months
The AP CCS Stage at the 6 months post baseline.
2 secondary outcomes
Exercise tolerance time
Time frame: 6 Months
Change in PET scan
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
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.
Lothar Faber, Prof. MD principal investigator
Heart and Diabetes Center North-Rhine Westfalia
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 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 7 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 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 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. 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?
Change in AP-CCS (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.