Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy (CSWTSPB40)
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ClinicalTrials.gov Identifier: NCT01631409 |
Recruitment Status
:
Withdrawn
(The study has been withdrawn due to organizational problems)
First Posted
: June 29, 2012
Last Update Posted
: April 8, 2014
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Condition or disease | Intervention/treatment |
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Coronary Heart Disease (CHD) | Other: Treatment of CHD risk factors Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril. Procedure: PCA Procedure: CABG Device: Cardiospec Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril |

This study has been designed and is conducted in accordance with the requirements of Helsinki Declaration, 6th edition, STROBE Statement, CONSORT 2010 Statement, and the State Standard of the Russian Federation "Guidelines for Clinical Investigations of Medical Devices" (ГОСТ Р ИСО 14155 - 2008), which is authentic to International Standards Organization standard 141555 - 2003.
According to the American Heart Association (AHA) 2011 report Russia leaves behind all other countries in the coronary heart disease mortality rate. This particularly means that the current methods of CHD treatment, namely: (1) optimal medical treatment (OMT), which includes intensive lifestyle and pharmacological management, (2) maximal antianginal medical therapy (MAAMT), which includes the employment of at least two classes of anti-ischemic therapies, (3) percutaneous coronary angioplasty (PCA), and (4) coronary artery bypass grafting (CABG) are not satisfactory enough in the concrete conditions of Russia. This indicate the urgent necessity of search for the alternative methods of CHD treatment. One of those methods is cardiac shock wave therapy.
The method of CSWT is not that new. The first publication is dated back to 1999. Since then a score of various in vivo as well clinical investigations has been conducted up to phase III. As a result, it has been demonstrated that (1)the method is practically safe and well-tolerated, and (2)it effectively alleviates angina and improves ECG, ECHO, and cardiac nuclear tests. Meanwhile, it is still not clear: (1) how long the remission lasts, (2)if CSWT exerts any influence on such basic health indicators as life span and reduction of major cardiovascular (CV) events like myocardial infarction (MI), (3)the place of CSWT in the overall system of conservative and surgical treatment of CHD, and (4)the long term effect of combined employment of CSWT with invasive and surgical modalities.
One of the causes of the such a state of things is the form in which CSWT research so far has been conducted, namely, the clinical trial. The high cost of that type of investigations precludes long-term follow-up. Besides, the desire to make the experimental and control group more homogeneous in the parallel design using multiple inclusion/exclusion criteria dramatically decreases sample representativeness. The observational design is mostly free of the above-mentioned shortcomings and in some instances allows to obtain important results which even theoretically are not accessible for investigations with strict control and randomization because of ethical and pragmatic considerations.
The aim of this study is to estimate the long term effectiveness of routine use of cardiac shock wave therapy in the general system of noninvasive, invasive, and surgical treatment of ischemic heart diseases in the conditions of a large general city hospital. The study will be conducted in the City Hospital No 40, Saint Petersburg, Russia (about the hospital see the link at the bottom of the protocol). It is a more than thousand bed general hospital. There are 55 thousand adults live within its zone of responsibility. From those there are approximately two thousand patients with CHD.
The algorithm of treatment selection in the hospital. The treatment of all patients begins from OMT. When OMT is not effective MAAMT is administered. The medical therapy is conducted strictly individually. When MAAMT fails the patient is offered PCA or CABG. That is, the general ideology of CHD therapy in the hospital follows the conventional international guidelines. CSWT is offered mostly in two cases: (1)when the patient refuses to undergo PCA or CABG, (2)when PCA or CABG are contraindicated for the patient. That is CSWT is factually used as the second line, reserve method.
In the hospital, CSWT is routinely employed for three years in correspondence with the prevailed international scheme: 3 sessions a week every first week for three consecutive months, 9 sessions altogether according to the guidelines approved by the First deputy of Saint Petersburg health care committee chairman. The CSWT is implemented by device Cardiospec manufactured by Medispec Ltd., headquarters in Germantown, MD, USA. The zone of reversed myocardial ischemia for CSWT application is determined by ECHO.
For the current study there will be formed seven observational cohorts (0-VI) by both diagnoses and interventions. The algorithm of the cohort formation in the current study is graphically demonstrated in the Diagram (see the link at the bottom of the protocol). The enrollment in the study will continue for 3 year. Taking into consideration the current CHD morbidity rate in the region 6,5‰, that allows to expect an additional one thousand patients for the investigation. Each participant will follow-up for five years. So the total length of the study is eight years.
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy in the General System of Noninvasive, Invasive, and Surgical Treatment of Ischemic Heart Disease in the Conditions of a Large General City Hospital |
Study Start Date : | September 2013 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |
Group/Cohort | Intervention/treatment |
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Cohort 0
Cohort 0 is allocated for the following two patient groups:
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Other: Treatment of CHD risk factors
Smoking cessation, low fat diet, body weight control, physical exercise program, and in some cases lipid-lowering medications, e.g. 3-hydroxy-3-methylglutaric acid-coenzyme A (HMG-CoA) reductase inhibitors, e.g. Simvastatin.
Other Name: Life style modification, sports, Zocor.
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Cohort I
Represents patients with Class 1 angina, who receive OMT.
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Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.
In the course of optimal medical treatment of Cohort I patient the life style modification is combined with one group of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) and lipid-lowering drugs (e.g. HMG-CoA reductase inhibitors).
Other Name: Halfprin 81, Nitrostat, Monoket, Tenormin, Vasotec, Norvasc.
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Cohort II
Comprises the patients with Class 2-4 angina, they are on MAAMT. The cohort is further divided in two groups:
They are those patients who then form cohorts III-VI. |
Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.
In the course of maximal antianginal medical therapy a Cohort II patient is provided with more than one group of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) combined with lowering-lipid drugs (e.g. HMG-CoA reductase inhibitors).
Other Name: Nitrostat, Monoket, Tenormin, Vasotec, Norvasc.
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Cohort III
Consists of patients already received PCA. They also continue various MAAMT.
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Procedure: PCA
Percutaneous coronary angioplasty
Other Name: e.g. coronary stenting
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Cohort IV
Includes the patients after CABG. They also are on various MAAMT.
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Procedure: CABG
Coronary artery bypass grafting
Other Name: coronary artery bypass surgery
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Cohort V
Incorporates the patients who have already underwent CSWT. They also receive individualized MAAMT.
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Device: Cardiospec
Cardiac shock wave therapy is implemented by device Cardiospec manufactured by Medispec Ltd.
Other Name: noninvasive cardiac revascularization
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Cohort VI
The cohort is composed of the patients who for various reasons have not been exposed to any intervention except MAAMT and continue to be on it. The algorithm of the cohort formation is graphically demonstrated in the Diagram "The logic tree of the cohort formation" (see the link at the bottom of the protocol). |
Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril
In the course of maximal antianginal medical therapy a Cohort VI patient is provided with more than two groups of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) combined with lowering-lipid drugs (e.g. HMG-CoA reductase inhibitors).
Other Name: Halfprin 81, Nitrostat, Monoket, Tenormin, Vasotec, Norvasc.
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- Outcome: death [ Time Frame: within three years after the enrolment ]the detailed circumstances and diagnose are determined by documents
- Outcome: major cardiovascular complications [ Time Frame: within three years after the enrolment ]the detailed circumstances and diagnose are determined by documents
- The number of hospitalizations [ Time Frame: within three years after the enrolment ]determined by documents
- The number of hospitalization days [ Time Frame: within three years after the enrolment ]determined by documents

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18 years and older.
- Diagnosed or suspected CHD.
- Willingness to participate in the study.
Exclusion Criteria:
- Inability of a patient to make an independent decision on participation in the study because of intellectual decline (article 29 of Helsinki Declaration)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631409
Study Director: | Sergey G Scherbak, MD, Prof. | City Hospital No 40, Saint Petersburg, Russia | |
Principal Investigator: | Dmitriy G Lisovetz, MD, CMedSc | City Hospital No 40, Saint Petersburg, Russia |
Additional Information:
Responsible Party: | City Hospital No 40, Saint Petersburg, Russia |
ClinicalTrials.gov Identifier: | NCT01631409 History of Changes |
Other Study ID Numbers: |
CSWT City Hosp No 40, SPB, Ru |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | April 8, 2014 |
Last Verified: | April 2014 |
Keywords provided by City Hospital No 40, Saint Petersburg, Russia:
clinical research coronary heart disease cardiac shock wave therapy ischemic heart disease |
myocardial revascularization observational research prospective research |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Aspirin Enalapril Enalaprilat Atenolol Amlodipine Isosorbide Isosorbide-5-mononitrate |
Isosorbide Dinitrate Nitroglycerin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors |