Shockwave Treatment for Advanced Angina in Maastricht

Study Overview
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Brief Summary
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There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called no-option patients. Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.

Official Title
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Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).

Conditions
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Angina

Intervention / Treatment
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* Procedure: shockwave treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation. Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI) Patient's conditions stable for at least 3 months Life expectancy of > 12 months. Exclusion Criteria: Unstable angina pectoris Haemodynamically significant valvular heart disease Myocardial infarction <3 month prior randomization Evidence of intracardiac thrombus Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses) 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 Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study. Patients who are unwilling or unable to cooperate with the study procedure. Age < 18 years Cardiac or pulmonary malignancy No informed consent Known depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: shockwave treatment|9 treatments in 3 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of exercise tolerance | Modified Bruce protocol, changes compared to the baseline | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of myocardial perfusion | myocardial perfusion scintigraphy changes compared to the baseline | 6 months | 
| Number of Patients with Adverse Events as a Measure of Safety | Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain. | 6 months | 
| Improvement of quality of life | Number of anginal attacks/week, use of nitrates/week | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anginal complaints, Lithotripsy, no option patients