Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03516643

Enrollment

122

Registered

2018-05-04

Start date

2009-01-31

Completion date

2018-04-30

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Angina Refractory

Brief summary

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.

Interventions

OTHERExtracorporeal Shockwave Myocardial Revascularization

extracorporeal shockwave in ischemic area evaluated by SPECT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Reduction of symptoms	1, 6, 12 months	Improvement of CCS class

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026