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NCT Number: NCT00662727

Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris

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.

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Key information

Conditions

Refractory Angina Pectoris Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah-Hebrew University Medical Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Device

Energy Density - 0.09 mJ/mm2

Other names: Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization

PLACEBO

Device

Placebo

Primary outcomes

  1. Total Exercise Time

    Time frame: 6 months

Secondary outcomes

  1. Change in SPECT

    Time frame: 6 months

  2. Change in AP-CCS

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medispec

Industry

Collaborators

  • Hadassah Medical Organization

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2008
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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