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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02339454
• Date of registration: 12/01/2015
• Prospective Registration: No
• Primary sponsor: Evgeny Shkolnik, MD
• Public title: Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris
• Scientific title: Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris - A Randomized, Double Blind, Placebo Controlled, Multicenter Study
• Date of first enrolment: May 2012
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02339454
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Lithuania, Russian Federation

Contacts

• Name: Jelena Celutkiene, MD, PhD
• Affiliation: Vilnius University Hospital, Santariskiu klinikos

• Name: Evgeny Shkolnik, MD, PhD
• Affiliation: Moscow State University of Medicine&Dentistry

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stable Angina Pectoris

Intervention(s)

Device: Placebo group

Device: Active treatment group

Primary Outcome(s)

Change in Total Exercise duration [Time Frame: 6 months]

Secondary Outcome(s)

Number of sublingual nitroglycerin consumption per week [Time Frame: 6 months]

Number of angina attacks per week [Time Frame: 6 months]

Seattle angina questionnaire score [Time Frame: 6 months]

CCS angina functional class [Time Frame: 6 months]

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]

Secondary ID(s)

ESMR-RCT-UP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vilnius University

Medispec