Overview

This trial is active, not recruiting.

Condition refractory angina pectoris
Treatments cardiac extracorporeal shockwave therapy generator (cardiospec), placebo
Phase phase 2
Sponsor Medispec
Collaborator Universität Duisburg-Essen
Start date June 2009
End date August 2012
Trial size 60 participants
Trial identifier NCT01241968, ESMR-RCT-DE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
A - Treatment group. Patients in this group receive actual shockwave therapy.
cardiac extracorporeal shockwave therapy generator (cardiospec) Cardiospec
Energy Density - 0.09 mJ/mm2
(Placebo Comparator)
Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
placebo
Placebo

Primary Outcomes

Measure
Total Exercise Time
time frame: 6 months
The incidence of adverse events at 12 months post treatment
time frame: 15 months

Secondary Outcomes

Measure
Change in Seattle Angina Questionnaire (SAQ)
time frame: 6 months
Change in AP-CCS
time frame: 6 months
Change in the Number of angina attacks
time frame: 6 months
Change in the Hospital Admission Rate
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Principal investigator Alexander Lind, MD
Description Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless. At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Medispec.