Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy

Condition(s) targeted: Coronary Heart Disease (CHD)

Intervention: Treatment of CHD risk factors (Other); Aspirin, Isosorbide mononitrate, Atenolol, Enalapril. (Drug); Aspirin, Isosorbide mononitrate, Atenolol, Enalapril. (Drug); PCA (Procedure); CABG (Procedure); Cardiospec (Device); Aspirin, Isosorbide mononitrate, Atenolol, Enalapril (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: City Hospital No 40, Saint Petersburg, Russia

Official(s) and/or principal investigator(s):
Sergey G Scherbak, MD, Prof., Study Director, Affiliation: City Hospital No 40, Saint Petersburg, Russia
Dmitriy G Lisovetz, MD, CMedSc, Principal Investigator, Affiliation: City Hospital No 40, Saint Petersburg, Russia

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.

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Outcome: death

Outcome: major cardiovascular complications

Secondary outcome:

The number of hospitalizations

The number of hospitalization days

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

The algorithm of the cohort formation in the current study is depicted in the Diagram "The logic tree of the cohort formation"

About the City Hospital No40, Saint Petersburg, Russia see its Wikipedia page

Starting date: September 2013
Last updated: April 7, 2014