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

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.

Conditions

• Coronary Heart Disease (CHD)

Interventions

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).

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).

PROCEDURE

PCA

Percutaneous coronary angioplasty

PROCEDURE

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).

Sponsors & Collaborators

• City Hospital No 40, Saint Petersburg, Russia

  lead OTHER

Principal Investigators

• Sergey G Scherbak, MD, Prof. · City Hospital No 40, Saint Petersburg, Russia

• Dmitriy G Lisovetz, MD, CMedSc · City Hospital No 40, Saint Petersburg, Russia

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2021-09-30

Completion

2021-09-30