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Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

Primary Purpose

Angina Refractory, Angina Pectoris

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Extracorporeal Shockwave Myocardial Revascularization

About this trial

This is an interventional treatment trial for Angina Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shockwave

Arm Description

Extracorporeal Shockwave treatment on Ischemic Myocardium

Outcomes

Primary Outcome Measures

Improvement of myocardial perfusion

Reduction in stress-induced ischemia at SPECT

Secondary Outcome Measures

Reduction of symptoms

Improvement of CCS class

Reduction of symptoms

Improvement of NYHA class

Reduction of symptoms

Reduction of oral nitrates need

Full Information

NCT ID

NCT03516643

First Posted

April 24, 2018

Last Updated

April 24, 2018

Sponsor

University of Turin, Italy

1. Study Identification

Unique Protocol Identification Number

NCT03516643

Brief Title

Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2009 (Actual)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina Refractory, Angina Pectoris

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Shockwave

Arm Type

Experimental

Arm Description

Extracorporeal Shockwave treatment on Ischemic Myocardium

Intervention Type

Other

Intervention Name(s)

Extracorporeal Shockwave Myocardial Revascularization

Other Intervention Name(s)

ESMR

Intervention Description

extracorporeal shockwave in ischemic area evaluated by SPECT

Primary Outcome Measure Information:

Title

Improvement of myocardial perfusion

Description

Reduction in stress-induced ischemia at SPECT

Time Frame

6months after ESMR

Secondary Outcome Measure Information:

Title

Reduction of symptoms

Description

Improvement of CCS class

Time Frame

1, 6, 12 months

Title

Reduction of symptoms

Description

Improvement of NYHA class

Time Frame

1, 6, 12 months

Title

Reduction of symptoms

Description

Reduction of oral nitrates need

Time Frame

1, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gianluca Alunni

Organizational Affiliation

Città della Salute e della Scienza of Torino

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

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