Loading clinical trials...

Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris | Clinical Trials | Clareo Health

SUSPENDEDPHASE1

Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

NCT01567592•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- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient will have an acoustic window to the myocardium by echocardiography. 4 chamber view (4CH), 2 chamber view (2CH), long axis (LAX) and short axis view (SAX) should be verified.
•2. Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT.
•3. Patient has documented myocardial reversible ischemia and or hibernation in at least one segment.
•4. Patient is classified as AP CCS of III or IV.
•5. Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
•6. Patients demonstrates exercise tolerance time (ETT) duration \< 10 minutes on a modified Bruce protocol on 2 consecutive tests (tests no less than 24 hours and no more than 2 weeks apart), with the second test within the difference of 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study).
•7. Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
•8. Patient has refused to undergo another angioplasty or CABG.
•9. Patient has signed an informed consent form.
•10. Patient's condition should be stable and should have a life expectancy of \> 12 months.
+1 more criteria

Exclusion Criteria

•1. Patient has chronic lung disease based on the GOLD criteria the patient has stage IV: Very Severe COPD according to Spirometric Classification of COPD, Severity based on Post-Bronchodilator
•2. Patient has emphysema and pulmonary fibrosis.
•3. Patient has active endocarditis, myocarditis or pericarditis.
•4. 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 was treated with TMR (Transmyocardial revascularization) or PMR (Percutaneous revascularization) , or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
•5. Patients who are unwilling or unable to cooperate with study procedure.
•6. Patients who are unwilling to quit smoking during the study procedure (including screening phase)
•7. Patients who had MI less than 3 months prior to treatment
•8. Patients with moderately severe or severe valvular disease. Moderately-severe and severe disease will be echographically diagnosed as follows:
•* Aortic Stenosis: Patients with Moderately-severe \[Peak Aortic valve gradient (AVG): 50-60 mmHg; Mean AVG: 30-40 mmHg; Effective orifice area (EOA): 0.75-1.0 cm2\] and severe Aortic Stenosis \[Peak AVG: above 60 mmHg; Mean AVG: above 40 mmHg; EOA: below 0.75 cm2\]
•* Mitral Stenosis: Patients with severe Mitral Stenosis \[EOA: below 1 cm2; Pressure half-time (ms): above 200 mmHg; Mean Mitral valve gradient: above 10 mmHg\]
+6 more criteria

Locations (1)

KMH Cardiology & Diagnostic Centers

Ontario, Canada

Key Dates

Start Date

March 1, 2009

Primary Completion Date

June 1, 2012

Completion Date

December 1, 2012

Last Updated

April 3, 2012

Enrollment

ESTIMATED participants

Conditions

Refractory Angina Pectoris

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

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: April 3, 2012Data 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 Shockwave Therapy for the Treatment of Chronic Angina Pectoris

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 Shock Wave Therapy for the Treatment of Ischemic Heart Disease