Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris

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

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.

Study Overview

• Status: Completed
• Conditions: Refractory Angina Pectoris
• Intervention / Treatment: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

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 treatment session (9 in total, spread over 9 weeks) are required for optimal results.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Academisch Ziekenhuis Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in AP-CCS	The AP-CCS stage at the 6 months post baseline.	6 months
Total Exercise time	The change in total exercise time (Exercise Tolerance Test- ETT) from baseline to 6 months post baseline.	6 months
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

Collaborators and Investigators

• Sponsor: Medispec
• Collaborators: Academisch Ziekenhuis Maastricht
• Investigators: Principal Investigator: Prof. Johannes Waltenberger, MD, PhD, Academisch Ziekenhuis Maastricht

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 10, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 17, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Refractory Angina; Myocardial Ischemia; Extracorporeal Shockwave Therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: ESMR-AZM-NL