Stable Angina Pectoris Clinical Trial
Official title:
Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris - A Randomized, Double Blind, Placebo Controlled, Multicenter Study
Verified date | April 2018 |
Source | Moscow State University of Medicine and Dentistry |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilnius University Hospital, Santariskiu klinkos | Vilnius | |
Russian Federation | Moscow state university of medicine&dentistry | Moscow |
Lead Sponsor | Collaborator |
---|---|
Evgeny Shkolnik, MD | Medispec, Vilnius University |
Lithuania, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to 1 mm ST-segment depression in modified Bruce treadmill test | 6 months | ||
Secondary | Time to angina in modified Bruce treadmill test | 6 months | ||
Secondary | Number of angina attacks per week | 6 months | ||
Secondary | Number of sublingual nitroglycerin consumption per week | 6 months | ||
Secondary | CCS angina functional class | 6 months | ||
Secondary | Seattle angina questionnaire score | 6 months |
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