Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516643
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 2018
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Refractory

Intervention

Other:
• Extracorporeal Shockwave Myocardial Revascularization
extracorporeal shockwave in ischemic area evaluated by SPECT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of myocardial perfusion	Reduction in stress-induced ischemia at SPECT	6months after ESMR
Secondary	Reduction of symptoms	Improvement of CCS class	1, 6, 12 months
Secondary	Reduction of symptoms	Improvement of NYHA class	1, 6, 12 months
Secondary	Reduction of symptoms	Reduction of oral nitrates need	1, 6, 12 months