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

NCT02339454 | Completed Phase 3

• 1 other identifier: ESMR-RCT-UP
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stable Angina Pectoris

Keywords

Cardiac Shock wave therapy; stable angina; exercise tolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

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

  6 months

• Time to angina in modified Bruce treadmill test

  6 months

• Number of angina attacks per week

  6 months

• Number of sublingual nitroglycerin consumption per week

  6 months

• CCS angina functional class

  6 months

Study Arms (2)

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).

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.

Device: Placebo group

Interventions

Active treatment group DEVICE

Energy Density - 0.09 mJ/mm2 Device: Active Applicator

Also known as: Cardiospec, Extracorporeal Shockwave Myocardial Revascularization (ESMR), Extracorporeal Cardiac Shock wave therapy (CSWT)

Active treatment group

Placebo group DEVICE

Placebo Applicator

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evgeny Shkolnik, MD: lead
• Vilnius University: collaborator
• Medispec: collaborator

Study Sites (2)

Vilnius University Hospital, Santariskiu klinkos

Vilnius, Lithuania

Location

Moscow state university of medicine&dentistry

Moscow, 127473, Russia

Location

Related Publications (1)

• 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.

  PMID: 31272465 DERIVED

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jelena Celutkiene, MD, PhD

  Vilnius University Hospital, Santariskiu klinikos

  PRINCIPAL INVESTIGATOR

• Evgeny Shkolnik, MD, PhD

  Moscow State University of Medicine&Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, department of functional methods in internal medicine

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 15, 2015
• Study Start: May 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

LI (1); RU (1)