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Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Primary Purpose

Refractory Angina Pectoris

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Placebo

About this trial

This is an interventional treatment trial for Refractory Angina Pectoris focused on measuring Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with chronic stable angina pectoris.
Documented myocardial segments with reversible ischemia
AP CCS class of III-IV.
Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
Exercise tolerance time < 10 min (modified Bruce)
Two ETT tests results (within two weeks) averaging no more than 25% of their mean
Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
Signed an IRB approved informed consent form.
Life expectancy of >12 months.

Exclusion Criteria:

Intraventricular thrombus
Malignancy in the area of treatment
Severe COPD
No smoking during the study procedure
MI less <3 months prior to treatment
Severe Valvular disease
Child bearing potential

Sites / Locations

Hadassah-Hebrew University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

A - Treatment group. Patients in this group receive actual shockwave therapy.

Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.

Outcomes

Primary Outcome Measures

Total Exercise Time

Secondary Outcome Measures

Change in SPECT

Change in AP-CCS

Full Information

NCT ID

NCT00662727

First Posted

April 14, 2008

Last Updated

February 17, 2013

Sponsor

Medispec

Collaborators

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00662727

Brief Title

Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medispec

Collaborators

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Angina Pectoris

Keywords

Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

A - Treatment group. Patients in this group receive actual shockwave therapy.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.

Intervention Type

Device

Intervention Name(s)

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Other Intervention Name(s)

Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization

Intervention Description

Energy Density - 0.09 mJ/mm2

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Total Exercise Time

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in SPECT

Time Frame

6 months

Title

Change in AP-CCS

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with chronic stable angina pectoris. Documented myocardial segments with reversible ischemia AP CCS class of III-IV. Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. Exercise tolerance time < 10 min (modified Bruce) Two ETT tests results (within two weeks) averaging no more than 25% of their mean Documented epicardial coronary artery disease not amenable to angioplasty or CABG. Signed an IRB approved informed consent form. Life expectancy of >12 months. Exclusion Criteria: Intraventricular thrombus Malignancy in the area of treatment Severe COPD No smoking during the study procedure MI less <3 months prior to treatment Severe Valvular disease Child bearing potential

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Leibowitz, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah-Hebrew University Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

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