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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Refractory Angina Pectoris
 Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Device: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by Medispec:

Primary Outcome Measures:
  • Total Exercise Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: January 2007
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662727

Locations
Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Medispec
Hadassah Medical Organization
Investigators
Principal Investigator: David Leibowitz, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Medispec
ClinicalTrials.gov Identifier: NCT00662727     History of Changes
Other Study ID Numbers: ESMR-RCT-IL
Study First Received: April 14, 2008
Last Updated: February 17, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Medispec:
Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013