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Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

NCT01241968•Medispec

View on ClinicalTrials.gov

Summary

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Detailed Description

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless. At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is diagnosed with chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation.
•Patient has documented myocardial segments with reversible ischemia.
•Patient is classified in AP CCS of III-IV.
•Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
•Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
•Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
•Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
•Patient has signed an IRB approved informed consent form.
•Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

Exclusion Criteria

•Patient is pregnant
•Patient has chronic lung disease including emphysema and pulmonary fibrosis.
•Patient has active endocarditis, myocarditis or pericarditis.
•Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
•Patients who are unwilling or unable to cooperate with study procedure

Locations (1)

Westdeutsches Herzzentrum ,Universität Duisburg/Essen

Essen, Germany

Key Dates

Start Date

June 1, 2009

Primary Completion Date

August 1, 2012

Completion Date

April 1, 2013

Last Updated

February 20, 2013

Enrollment

ESTIMATED participants

Conditions

Refractory Angina Pectoris

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

DEVICE

Placebo

DEVICE

IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)

NCT05174572

Refractory Angina Pectoris

View study

UNKNOWNNA

Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris

NCT04915157

Refractory Angina PectorisSpinal Cord Stimulation

View study

WITHDRAWNNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

Inclusion Criteria

Exclusion Criteria

IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)

Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris

Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients

Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris