Stable Angina PectorisPhase 3NCT02339454
Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris
A Phase 3 study testing Active treatment group in people with Stable Angina Pectoris, run by Evgeny Shkolnik, MD at 2 sites in 2 countries.
Trial summary
Low intensity shockwaves have been proven in animal and pilot clinical studies to induce local growth of new blood vessels. Small single-center clinical trials with shockwave therapy showed promising results in reducing angina symptoms, improving perfusion and contractility in patients with refractory angina and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina Pectoris
- What is being tested?
- Active treatment group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Dec 2017
- Phase
- Phase 3
- 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
- Male and female patients (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomized partner).
- Patients aged ≥ 18 years.
- Patients with coronary artery disease confirmed by angiography, prior MI, prior revascularization (PCI, CABG) and with exercise angina not controlled by the optimal medical therapy.
- Patient should be on a stable dosage of medication used to treat angina for at least 4 weeks prior to enrollment.
- ST-segment depression ≥ 1mm during exercise ECG.
- Able and willing to sign informed consent and to comply with study procedures.
- Written informed consent prior to enrolment into the study.
Who cannot join
- Angina at rest.
- ECG abnormalities at rest (left bundle-branch block, resting ST-segment depression ≥ 1mm, digoxin therapy, WPW-syndrome).
- Planned coronary intervention or CABG within 6 months.
- Heart failure (class III or IV NYHA).
- Moderate-severe hypertension (SBP>160 mmHg and/or DBP>100 mmHg).
- Hypotension (SBP<100 mmHg).
Show all 18Show fewer
- Acute coronary syndrome or coronary revascularization procedure within the prior 3 months before enrolment.
- Females who are pregnant or nursing.
- Any clinically relevant hematological or biochemical abnormality on routine screening, according to Investigator's judgment.
- Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.).
- Renal impairment defined as Creatinine >150 mcmol/l.
- Mild, moderate or severe hepatic impairment or hepatic insufficiency defined as: SGOT or SGPT > 3 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit
- Existing contraindications for exercise testing (e.g. acute myocarditis or pericarditis, DVT, severe aortic stenosis)
- Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances.
- Conditions which in the Investigator's opinion may interfere with the study's execution or due to which the patient should not participate for safety reasons.
- Risk of low patient cooperation.
- Inability or unwillingness to issue the informed consent.
- 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 cardiac shock wave therapy machine of a competitor company within 3 months of entry into the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris - A Randomized, Double Blind, Placebo Controlled, Multicenter Study
Low intensity shockwaves have been proven in animal and pilot clinical studies to induce local growth of new blood vessels. Small single-center clinical trials with shockwave therapy showed promising results in reducing angina symptoms, improving perfusion and contractility in patients with refractory angina and stress-induced ischemia on imaging test.
The hypothesis of this study is that shockwave therapy could improve angina symptoms and exercise tolerance in broader population of patients with stable angina regardless of imaging test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in patients with stable angina.
Read the detailed description
Low intensity shockwaves (0.09 millijoule/mm2) are delivered to myocardial 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 (ECG) to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes modified Bruce treadmill test, to assess exercise induced ischemia.
Exercise induced ECG ischemia is defined as the new development of horizontal or down - sloping ST segment depression (≥1 mm at 60 ms after J point) versus baseline tracing.
Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session.
During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
The spots are localized by the ultra-sound device and the shockwaves are focused to this area. Several treatments are required for optimal results.
- Conditions
- Stable Angina Pectoris
- Being tested
- Active treatment group, Placebo group
- Keywords
- Cardiac Shock wave therapy, stable angina, exercise tolerance
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatment groupDevice
Also called Cardiospec, Extracorporeal Shockwave Myocardial Revascularization (ESMR), Extracorporeal Cardiac Shock wave therapy (CSWT)
Energy Density - 0.09 mJ/mm2 Device: Active Applicator
Placebo groupDevice
Placebo Applicator
| Study group | Role | What they receive |
|---|---|---|
| Active treatment group | Active comparator | Patients in this group receive actual shockwave therapy. Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session.
During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). Receives: Device: Active treatment group |
| Placebo group | Placebo comparator | This group of patients undergoes the same procedure as the treatment group; however shockwaves are not delivered to the heart. Receives: Device: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Exercise duration
To evaluate if ESMR able to improve total exercise duration in modified Bruce treadmill test.
Patients will be assessed at baseline visit (screening) and 6 months after the first treatment.
Measured: 6 months
Secondary outcomes (6)
Time to 1 mm ST-segment depression in modified Bruce treadmill test
Measured: 6 months
Time to angina in modified Bruce treadmill test
Measured: 6 months
Number of angina attacks per week
Measured: 6 months
Number of sublingual nitroglycerin consumption per week
Measured: 6 months
CCS angina functional class
Measured: 6 months
Seattle angina questionnaire score
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 posted15 Jan 2015 (estimated)
- Study startMay 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evgeny Shkolnik, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University, Medispec
- Responsible party
- Sponsor-investigator, Evgeny Shkolnik, MD, Moscow State University of Medicine and Dentistry
- Investigators
- Jelena Celutkiene, MD, PhD, Principal investigator, Vilnius University Hospital, Santariskiu klinikosEvgeny Shkolnik, MD, PhD, Principal investigator, Moscow State University of Medicine&Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339454
- Sponsor's protocol ID
- ESMR-RCT-UP
- Status last verified
- Apr 2018
- First submitted
- 12 Jan 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Celutkiene J, Burneikaite G, Shkolnik E, Jakutis G, Vajauskas D, Cerlinskaite K, Zuoziene G, Petrauskiene B, Puronaite R, Komiagiene R, Butkuviene I, Steponeniene R, Misiura J, Laucevicius A. The effect of cardiac shock wave therapy on myocardial function and perfusion in the randomized, triple-blind, sham-procedure controlled study. Cardiovasc Ultrasound. 2019 Jul 4;17(1):13. doi: 10.1186/s12947-019-0163-1.
PubMed 31272465
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris - A Randomized, Double Blind, Placebo Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT02339454
- Acronym / sponsor ID
- ESMR-RCT-UP
- Conditions
- Stable Angina Pectoris
- Keywords
- Cardiac Shock wave therapy, stable angina, exercise tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Evgeny Shkolnik, MDUniversity, hospital or other
- Collaborators
- Vilnius University, Medispec
- Study start
- May 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jan 2015 (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 and pilot clinical studies to induce local growth of new blood vessels. Small single-center clinical trials with shockwave therapy showed promising results in reducing angina symptoms, improving perfusion and contractility in patients with refractory angina and stress-induced ischemia on imaging test.
The hypothesis of this study is that shockwave therapy could improve angina symptoms and exercise tolerance in broader population of patients with stable angina regardless of imaging test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in patients with stable angina.
Detailed description
Low intensity shockwaves (0.09 millijoule/mm2) are delivered to myocardial 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 (ECG) to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes modified Bruce treadmill test, to assess exercise induced ischemia.
Exercise induced ECG ischemia is defined as the new development of horizontal or down - sloping ST segment depression (≥1 mm at 60 ms after J point) versus baseline tracing.
Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session.
During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions).
The spots are localized by the ultra-sound device and the shockwaves are focused to this area. Several treatments are required for optimal results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment group | Active comparator | Device: Active treatment groupPatients in this group receive actual shockwave therapy. Study treatment consists of 9 sessions, with 3 sessions per week 1, 5 and 9. 100 shocks are delivered per spot, 1200 shocks per session. During 1st treatment week ESMR will be delivered 3 times (every other day) to basal segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). During 2nd treatment week ESMR will be delivered 3 times (every other day) to middle segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). During 3rd treatment week ESMR will be delivered 3 times (every other day) to apical segments (2 spots in each wall in apical 4-, 2-, 3- chamber positions). |
| Placebo group | Placebo comparator | Device: Placebo groupThis group of patients undergoes 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 (7 listed)
- Male and female patients (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomized partner).
- Patients aged ≥ 18 years.
- Patients with coronary artery disease confirmed by angiography, prior MI, prior revascularization (PCI, CABG) and with exercise angina not controlled by the optimal medical therapy.
- Patient should be on a stable dosage of medication used to treat angina for at least 4 weeks prior to enrollment.
- ST-segment depression ≥ 1mm during exercise ECG.
Key exclusion criteria (18 listed)
- Angina at rest.
- ECG abnormalities at rest (left bundle-branch block, resting ST-segment depression ≥ 1mm, digoxin therapy, WPW-syndrome).
- Planned coronary intervention or CABG within 6 months.
- Heart failure (class III or IV NYHA).
- Moderate-severe hypertension (SBP>160 mmHg and/or DBP>100 mmHg).
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 |
|---|---|---|
| Active treatment groupAlso: Cardiospec, Extracorporeal Shockwave Myocardial Revascularization (ESMR), Extracorporeal Cardiac Shock wave therapy (CSWT)Energy Density - 0.09 mJ/mm2 Device: Active Applicator | Device | Active treatment group |
| Placebo groupPlacebo Applicator | Device | Placebo group |
Primary outcome
Change in Total Exercise duration
Time frame: 6 months
To evaluate if ESMR able to improve total exercise duration in modified Bruce treadmill test. Patients will be assessed at baseline visit (screening) and 6 months after the first treatment.
6 secondary outcomes
Time to 1 mm ST-segment depression in modified Bruce treadmill test
Time frame: 6 months
Time to angina in modified Bruce treadmill test
Time frame: 6 months
Number of angina attacks per week
Time frame: 6 months
Number of sublingual nitroglycerin consumption per week
Time frame: 6 months
CCS angina functional class
Time frame: 6 months
Seattle angina questionnaire score
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 10 Apr 2018.
- Derived from this study: PubMed 31272465Celutkiene J, Burneikaite G, Shkolnik E, Jakutis G, Vajauskas D, Cerlinskaite K, Zuoziene G, Petrauskiene B, Puronaite R, Komiagiene R, Butkuviene I, Steponeniene R, Misiura J, Laucevicius A. The effect of cardiac shock wave therapy on myocardial function and perfusion in the randomized, triple-blind, sham-procedure controlled study. Cardiovasc Ultrasound. 2019 Jul 4;17(1):13. doi: 10.1186/s12947-019-0163-1.
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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.
Jelena Celutkiene, MD, PhD principal investigator
Vilnius University Hospital, Santariskiu klinikos
Evgeny Shkolnik, MD, PhD principal investigator
Moscow State University of Medicine&Dentistry
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active treatment group in people with Stable Angina Pectoris, run by Evgeny Shkolnik, MD at 2 sites in 2 countries.
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 7 inclusion and 18 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania, Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Total Exercise duration (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339454, which also lists 1 linked publication.
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 10 Apr 2018.