Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris
Randomized, Placebo Controlled, Double Blind Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
1 other identifier
interventional
28
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 14, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 20, 2013
February 1, 2013
5.4 years
April 14, 2008
February 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Exercise Time
6 months
Secondary Outcomes (2)
Change in SPECT
6 months
Change in AP-CCS
6 months
Study Arms (2)
A
ACTIVE COMPARATORA - Treatment group. Patients in this group receive actual shockwave therapy.
B
PLACEBO COMPARATORPlacebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart.
Interventions
Energy Density - 0.09 mJ/mm2
Eligibility Criteria
You may qualify if:
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time \< 10 min (modified Bruce)
- Two ETT tests results (within two weeks) averaging no more than 25% of their mean
- Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Signed an IRB approved informed consent form.
- Life expectancy of \>12 months.
You may not qualify if:
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less \<3 months prior to treatment
- Severe Valvular disease
- Child bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medispeclead
- Hadassah Medical Organizationcollaborator
Study Sites (1)
Hadassah-Hebrew University Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Leibowitz, MD
Hadassah Medical Organization
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
April 14, 2008
First Posted
April 21, 2008
Study Start
January 1, 2007
Primary Completion
June 1, 2012
Study Completion
November 1, 2012
Last Updated
February 20, 2013
Record last verified: 2013-02