Extracorporeal Shock Wave Therapy for the Treatment of Ischemic Heart Disease

NCT01241968 | Unknown Phase 2

• 1 other identifier: ESMR-RCT-DE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Conditions

Refractory Angina Pectoris

Keywords

Extracorporeal Shockwave Therapy; Myocardial Ischemia; Refractory Angina

Outcome Measures

Primary Outcomes (2)

• Total Exercise Time

  The primary efficacy endpoint is the change in maximal stress exercise capacity using the modified Bruce exercise test from baseline to the 6 months post-baseline assessment.

  6 months

• The incidence of adverse events at 12 months post treatment

  Incidence of patient complications, adverse reactions and rise in cardiac enzymes, blood count, platelate count renal and hepatic function, and Troponin levels, as well as E.C.G. changes, 12 months post treatment.

  15 months

Secondary Outcomes (4)

• Change in Seattle Angina Questionnaire (SAQ)

  6 months

• Change in AP-CCS

  6 months

• Change in the Number of angina attacks

  6 months

• Change in the Hospital Admission Rate

  6 months

Study Arms (2)

A

ACTIVE COMPARATOR

A - Treatment group. Patients in this group receive actual shockwave therapy.

Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

B

PLACEBO COMPARATOR

Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.

Device: Placebo

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) DEVICE

Energy Density - 0.09 mJ/mm2

Also known as: Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization

A

Placebo DEVICE

Placebo

B

Eligibility Criteria

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

You may qualify if:

• Patient is diagnosed with chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation.
• Patient has documented myocardial segments with reversible ischemia.
• Patient is classified in AP CCS of III-IV.
• Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
• Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
• Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
• Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
• Patient has signed an IRB approved informed consent form.
• Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

You may not qualify if:

• Patient is pregnant
• Patient has chronic lung disease including emphysema and pulmonary fibrosis.
• Patient has active endocarditis, myocarditis or pericarditis.
• Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
• Patients who are unwilling or unable to cooperate with study procedure

Sponsors & Collaborators

• Medispec: lead
• Universität Duisburg-Essen: collaborator

Study Sites (1)

Westdeutsches Herzzentrum ,Universität Duisburg/Essen

Essen, Germany

Location

MeSH Terms

Conditions

Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander Lind, MD

  Westdeutsches Herzzentrum ,Universität Duisburg/Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: June 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: April 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

DE (1)