Angina Pectoris Clinical Trial
Official title:
Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort
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 |
Verified date | April 2018 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
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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