Refractory Angina PectorisPhase 2NCT00662727
Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
A Phase 2 study testing Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) in people with Refractory Angina Pectoris, run by Medispec at 1 site in Israel.
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
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Nov 2012
- 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
- 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
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- 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: 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- 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), 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
Measured: 6 months
Secondary outcomes (2)
Change in SPECT
Measured: 6 months
Change in AP-CCS
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 posted21 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2012
- Study completionNov 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- David Leibowitz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662727
- Sponsor's protocol ID
- ESMR-RCT-IL
- Status last verified
- Feb 2013
- First submitted
- 14 Apr 2008
- 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
- NCT00662727
- Acronym / sponsor ID
- ESMR-RCT-IL
- Conditions
- Refractory Angina Pectoris
- Keywords
- Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- Jan 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Apr 2008 (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
- 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)
- 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 | A |
| PlaceboPlacebo | Device | B |
Primary outcome
Total Exercise Time
Time frame: 6 months
2 secondary outcomes
Change in SPECT
Time frame: 6 months
Change in AP-CCS
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.
David Leibowitz, MD principal investigator
Hadassah Medical Organization
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 Israel.
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: 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 Israel. 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?
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?
Total Exercise Time (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.