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

NCT01631409 | Withdrawn DMC

• 1 other identifier: CSWT City Hosp No 40, SPB, Ru
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

clinical research; coronary heart disease; cardiac shock wave therapy; ischemic heart disease; myocardial revascularization; observational research; prospective research

Outcome Measures

Primary Outcomes (2)

• Outcome: death

  the detailed circumstances and diagnose are determined by documents

  within three years after the enrolment

• Outcome: major cardiovascular complications

  the detailed circumstances and diagnose are determined by documents

  within three years after the enrolment

Secondary Outcomes (2)

• The number of hospitalizations

  within three years after the enrolment

• The number of hospitalization days

  within three years after the enrolment

Study Arms (7)

Cohort 0

Cohort 0 is allocated for the following two patient groups: 1. The patients with suspicion of angina although in whom the thorough investigation has not revealed CHD and the pain syndrome has been received the extracardiac interpretation (e.g. vertebral osteochondrosis, left side humeroscapular periarthritis, herpes zoster, intercostal neuralgia Tietze syndrome etc.) 2. The patients with subclinical manifestation of coronary atherosclerosis without angina (Class 0 angina, here and further is according to the Canadian Cardiovascular Society Angina Classification). This subgroup of the patients is recommended the proper diet, life style modification, lipid targeting medications in some cases, and no antianginal treatment.

Other: Treatment of CHD risk factors

Cohort I

Represents patients with Class 1 angina, who receive OMT.

Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.

Cohort II

Comprises the patients with Class 2-4 angina, they are on MAAMT. The cohort is further divided in two groups: 1. The patients for whom MAAMT is effective. 2. The patients for whom MAAMT is not effective or not sufficiently effective, although those patients have not received any invasive, surgical or CSWT interventions yet. They are those patients who then form cohorts III-VI.

Drug: Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.

Cohort III

Consists of patients already received PCA. They also continue various MAAMT.

Procedure: PCA

Cohort IV

Includes the patients after CABG. They also are on various MAAMT.

Procedure: CABG

Cohort V

Incorporates the patients who have already underwent CSWT. They also receive individualized MAAMT.

Device: Cardiospec

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

Interventions

Treatment of CHD risk factors OTHER

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.

Also known as: Life style modification, sports, Zocor.

Cohort 0

Aspirin, Isosorbide mononitrate, Atenolol, Enalapril DRUG

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).

Also known as: Halfprin 81, Nitrostat, Monoket, Tenormin, Vasotec, Norvasc.

Cohort VI

PCA PROCEDURE

Percutaneous coronary angioplasty

Also known as: e.g. coronary stenting

Cohort III

CABG PROCEDURE

Coronary artery bypass grafting

Also known as: coronary artery bypass surgery

Cohort IV

Cardiospec DEVICE

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

Also known as: noninvasive cardiac revascularization

Cohort V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are 55 thousand adults live within the zone of responsibility of the hospital. From those there are approximately 2 thousand patients with CHD.

You may qualify if:

• Age 18 years and older.
• Diagnosed or suspected CHD.
• Willingness to participate in the study.

You may not qualify if:

• Inability of a patient to make an independent decision on participation in the study because of intellectual decline (article 29 of Helsinki Declaration)

Sponsors & Collaborators

• City Hospital No 40, Saint Petersburg, Russia: lead

Related Links

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

MeSH Terms

Conditions

Coronary Disease; Myocardial Ischemia

Interventions

Simvastatin; Aspirin; isosorbide-5-mononitrate; Atenolol; Enalapril; Nitroglycerin; Enalaprilat; Amlodipine; Passive Cutaneous Anaphylaxis; Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Nitro Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Sergey G Scherbak, MD, Prof.

  City Hospital No 40, Saint Petersburg, Russia

  STUDY DIRECTOR

• Dmitriy G Lisovetz, MD, CMedSc

  City Hospital No 40, Saint Petersburg, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: June 29, 2012
• Study Start: September 1, 2013
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 8, 2014

Record last verified: 2014-04