Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

Study Overview
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Brief Summary
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This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.

Official Title
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Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort

Conditions
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Angina Refractory, Angina Pectoris

Intervention / Treatment
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* Other: Extracorporeal Shockwave Myocardial Revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of coronary artery disease; refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon); stable maximal medical therapy for at least 6 weeks; stress-induced ischemia at baseline SPECT; left ventricular ejection fraction higher than 40%; age higher than 18 years. Exclusion Criteria: myocardial infarction or unstable angina in the previous 3 months, acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwave<br>Extracorporeal Shockwave treatment on Ischemic Myocardium | Other: Extracorporeal Shockwave Myocardial Revascularization<br>* extracorporeal shockwave in ischemic area evaluated by SPECT<br>* Other names: ESMR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of myocardial perfusion | Reduction in stress-induced ischemia at SPECT | 6months after ESMR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptoms | Improvement of CCS class | 1, 6, 12 months | 
| Reduction of symptoms | Improvement of NYHA class | 1, 6, 12 months | 
| Reduction of symptoms | Reduction of oral nitrates need | 1, 6, 12 months |