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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03516643
Other study ID # 01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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