Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy
Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy
This study is dedicated to determination of the long term effectiveness of coronary heart
 disease (CHD) treatments - cardiac shock wave therapy (CSWT) in comparison with other kinds
 of medical and surgical treatment. For that purpose the investigators will observe the
 patients with CHD who enrolled in this study in their routine course of treatment. But the
 investigators will not interfere with the patient treatment. Each participant will be
 followed-up for five years. The collected data will allow to determine if the particular
 method, CSWT, could really make any additional contribution to the more traditional methods
 of CHD treatment and if the CSWT is only temporarily effective or could exert the long term
 effect as well.
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.
Inclusion Criteria:

 1. Age 18 years and older.

 2. Diagnosed or suspected CHD.

 3. 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)