Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

NCT ID: NCT03516643

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2018-04-30

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.

Conditions

Angina Refractory; Angina Pectoris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shockwave

Extracorporeal Shockwave treatment on Ischemic Myocardium

Group Type: EXPERIMENTAL

Extracorporeal Shockwave Myocardial Revascularization

Intervention Type: OTHER

extracorporeal shockwave in ischemic area evaluated by SPECT

Interventions

Extracorporeal Shockwave Myocardial Revascularization

extracorporeal shockwave in ischemic area evaluated by SPECT

Intervention Type: OTHER

Other Intervention Names

ESMR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Alunni

MD, Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Alunni

Role: PRINCIPAL_INVESTIGATOR

Città della Salute e della Scienza of Torino

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id