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Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris

Primary Purpose

Stable Angina Pectoris

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Active treatment group

Placebo group

About this trial

This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Cardiac Shock wave therapy, stable angina, exercise tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).
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.

Sites / Locations

Vilnius University Hospital, Santariskiu klinkos
Moscow state university of medicine&dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active treatment group

Placebo group

Arm Description

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).

This group of patients undergoes the same procedure as the treatment group; however shockwaves are not delivered to the heart.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to 1 mm ST-segment depression in modified Bruce treadmill test

Time to angina in modified Bruce treadmill test

Number of angina attacks per week

Number of sublingual nitroglycerin consumption per week

CCS angina functional class

Seattle angina questionnaire score

Full Information

NCT ID

NCT02339454

First Posted

January 12, 2015

Last Updated

April 7, 2018

Sponsor

Evgeny Shkolnik, MD

Collaborators

Vilnius University, Medispec

1. Study Identification

Unique Protocol Identification Number

NCT02339454

Brief Title

Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris

Official Title

Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris - A Randomized, Double Blind, Placebo Controlled, Multicenter Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Evgeny Shkolnik, MD

Collaborators

Vilnius University, Medispec

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Angina Pectoris

Keywords

Cardiac Shock wave therapy, stable angina, exercise tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment group

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

This group of patients undergoes the same procedure as the treatment group; however shockwaves are not delivered to the heart.

Intervention Type

Device

Intervention Name(s)

Active treatment group

Other Intervention Name(s)

Cardiospec, Extracorporeal Shockwave Myocardial Revascularization (ESMR), Extracorporeal Cardiac Shock wave therapy (CSWT)

Intervention Description

Energy Density - 0.09 mJ/mm2 Device: Active Applicator

Intervention Type

Device

Intervention Name(s)

Placebo group

Intervention Description

Placebo Applicator

Primary Outcome Measure Information:

Title

Change in Total Exercise duration

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time to 1 mm ST-segment depression in modified Bruce treadmill test

Time Frame

6 months

Title

Time to angina in modified Bruce treadmill test

Time Frame

6 months

Title

Number of angina attacks per week

Time Frame

6 months

Title

Number of sublingual nitroglycerin consumption per week

Time Frame

6 months

Title

CCS angina functional class

Time Frame

6 months

Title

Seattle angina questionnaire score

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jelena Celutkiene, MD, PhD

Organizational Affiliation

Vilnius University Hospital, Santariskiu klinikos

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Evgeny Shkolnik, MD, PhD

Organizational Affiliation

Moscow State University of Medicine&Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vilnius University Hospital, Santariskiu klinkos

City

Vilnius

Country

Lithuania

Facility Name

Moscow state university of medicine&dentistry

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

31272465

Citation

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.

Results Reference

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Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris

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