Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Refractory Angina Pectoris Clinical Trial

Official title:

Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01567644
• Other study ID #: ESMR-NRW-DE
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 15, 2010
• Last updated: April 1, 2012
• Start date: January 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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- 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina Pectoris

Intervention

Device:
• Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center North-Rhine Westfalia	Bad Oeynhausen

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AP-CCS	The AP CCS Stage at the 6 months post baseline.	6 Months	No
Secondary	Exercise tolerance time	The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline	6 Months	No
Secondary	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.	6 months	No