Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris

Refractory Angina Pectoris Clinical Trial

Official title:

Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219218
• Other study ID #: ESMR-AZM-NL
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2010
• Last updated: February 17, 2013
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• 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-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 treatment session (9 in total, spread over 9 weeks) are required for optimal results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. Diagnosis is based on medical history, complete physical evaluation.

• Patient has documented myocardial segments with reversible ischemia.

• Patient is classified in AP CCS of III-IV.

• Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.

• Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).

• Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).

• Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.

• Patient has signed an IRB approved informed consent form.

• Patient's condition should be stable and should have a life expectancy of >12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

Exclusion Criteria:

• Patient is pregnant

• Patient has chronic lung disease including emphysema and pulmonary fibrosis.

• Patient has active endocarditis, myocarditis or pericarditis.

• Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.

• Patients who are unwilling or unable to cooperate with study procedure

Study Design

Allocation: Non-Randomized, 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
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Academisch Ziekenhuis Maastricht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Angina	Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment	6 months	No
Secondary	Change in SPECT	The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segment model)	6 months	No
Secondary	Change in AP-CCS	The AP-CCS stage at the 6 months post baseline.	6 months	No
Secondary	Total Exercise time	The change in total exercise time (Exercise Tolerance Test- ETT) from baseline to 6 months post baseline.	6 months	No
Secondary	Number of Angina attacks (patient diary)	The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.	6 months	No