Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina

NCT03516643 | Completed DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Improvement of myocardial perfusion

  Reduction in stress-induced ischemia at SPECT

  6months after ESMR

Secondary Outcomes (3)

• Reduction of symptoms

  1, 6, 12 months

• Reduction of symptoms

  1, 6, 12 months

• Reduction of symptoms

  1, 6, 12 months

Study Arms (1)

Shockwave

EXPERIMENTAL

Extracorporeal Shockwave treatment on Ischemic Myocardium

Other: Extracorporeal Shockwave Myocardial Revascularization

Interventions

Extracorporeal Shockwave Myocardial Revascularization OTHER

extracorporeal shockwave in ischemic area evaluated by SPECT

Also known as: ESMR

Shockwave

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Alunni

  Città della Salute e della Scienza of Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Cardiologist

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 4, 2018
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share