Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

February 17, 2013 updated by: Medispec

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah-Hebrew University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
A - Treatment group. Patients in this group receive actual shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
Other Names:
  • Cardiospec
  • ESMR therapy
  • Extracorporeal Shockwave Myocardial Revascularization
Placebo Comparator: B
Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
Device: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Exercise Time
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in SPECT
Time Frame: 6 months
6 months
Change in AP-CCS
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medispec

Collaborators

Hadassah Medical Organization

Investigators

  • Principal Investigator: David Leibowitz, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 17, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESMR-RCT-IL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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