Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

This study has been completed.
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Medispec
ClinicalTrials.gov Identifier:
NCT00662727
First received: April 14, 2008
Last updated: February 17, 2013
Last verified: February 2013

April 14, 2008
February 17, 2013
January 2007
June 2012   (final data collection date for primary outcome measure)
Total Exercise Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662727 on ClinicalTrials.gov Archive Site
  • Change in SPECT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in AP-CCS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Refractory Angina Pectoris
  • Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
    Energy Density - 0.09 mJ/mm2
    Other Names:
    • Cardiospec
    • ESMR therapy
    • Extracorporeal Shockwave Myocardial Revascularization
  • Device: Placebo
    Placebo
  • Active Comparator: A
    A - Treatment group. Patients in this group receive actual shockwave therapy.
    Intervention: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
  • 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.
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00662727
ESMR-RCT-IL
No
Medispec
Medispec
Hadassah Medical Organization
Principal Investigator: David Leibowitz, MD Hadassah Medical Organization
Medispec
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP