Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Medispec35 enrolled

Overview

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- PET 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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractory Angina Pectoris

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)DEVICE

Energy Density - 0.09 mJ/mm2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart and Diabetes Center North-Rhine Westfalia

Bad Oeynhausen, Germany

Outcomes

Primary Outcomes

Change in AP-CCS

The AP CCS Stage at the 6 months post baseline.

Time frame: 6 Months

Secondary Outcomes

Exercise tolerance time

The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline

Time frame: 6 Months

Change in PET scan

The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.

Time frame: 6 months

Data from ClinicalTrials.gov

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