Clinical trial NCT01219218: Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris
Official title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM). A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory Angina Pectoris
Keywords: Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Academisch Ziekenhuis Maastricht
First posted: 2010-10-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Angina
timeFrame: 6 months
Secondary outcomes:
measure: Change in SPECT
timeFrame: 6 months
measure: Change in AP-CCS
timeFrame: 6 months
measure: Total Exercise time
timeFrame: 6 months
measure: Number of Angina attacks (patient diary)
timeFrame: 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
Study officials:
affiliation: Academisch Ziekenhuis Maastricht
name: Prof. Johannes Waltenberger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: