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

Coronary Heart Disease (CHD) Clinical Trial

— CSWTSPB40  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631409
• Other study ID #: CSWT City Hosp No 40, SPB, Ru
• Status: Withdrawn
• Phase: N/A
• First received: June 24, 2012
• Last updated: April 7, 2014
• Start date: September 2013
• Est. completion date: September 2021

Study information

• Verified date: April 2014
• Source: City Hospital No 40, Saint Petersburg, Russia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease (CHD)
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

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).
• 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).

Procedure:
• PCA
Percutaneous coronary angioplasty
• CABG
Coronary artery bypass grafting

Device:
• Cardiospec
Cardiac shock wave therapy is implemented by device Cardiospec manufactured by Medispec Ltd.

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
City Hospital No 40, Saint Petersburg, Russia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome: death	the detailed circumstances and diagnose are determined by documents	within three years after the enrolment	No
Primary	Outcome: major cardiovascular complications	the detailed circumstances and diagnose are determined by documents	within three years after the enrolment	No
Secondary	The number of hospitalizations	determined by documents	within three years after the enrolment	No
Secondary	The number of hospitalization days	determined by documents	within three years after the enrolment	No

External Links

•   About the City Hospital No40, Saint Petersburg, Russia see its Wikipedia page
•   The algorithm of the cohort formation in the current study is depicted in the Diagram "The logic tree of the cohort formation"