MedTrace Logo

Efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy in Patients With Stable Angina Pectoris

NCT02339454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-04-10

No results posted yet for this study

Summary

Low intensity shockwaves have been proven in animal and pilot clinical studies to induce local growth of new blood vessels. Small single-center clinical trials with shockwave therapy showed promising results in reducing angina symptoms, improving perfusion and contractility in patients with refractory angina and stress-induced ischemia on imaging test.

The hypothesis of this study is that shockwave therapy could improve angina symptoms and exercise tolerance in broader population of patients with stable angina regardless of imaging test results Study aims to demonstrate anti-anginal efficacy of Extracorporeal Shockwave Myocardial Revascularization Therapy (ESMR), on top of stable optimal medical treatment in patients with stable angina.

Conditions

  • Stable Angina Pectoris

Interventions

DEVICE

Active treatment group

Energy Density - 0.09 mJ/mm2 Device: Active Applicator

DEVICE

Placebo group

Placebo Applicator

Sponsors & Collaborators

  • Vilnius University

    collaborator OTHER

  • Medispec

    collaborator INDUSTRY

  • Evgeny Shkolnik, MD

    lead OTHER

Principal Investigators

  • Jelena Celutkiene, MD, PhD · Vilnius University Hospital, Santariskiu klinikos

  • Evgeny Shkolnik, MD, PhD · Moscow State University of Medicine&Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Lithuania
  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339454 on ClinicalTrials.gov