Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris - Full Text View

Sponsors and Collaborators:	Medispec Hadassah-Hebrew University Medical Center
Information provided by:	Medispec
ClinicalTrials.gov Identifier:	NCT00662727

Purpose

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.

Condition	Intervention	Phase
Refractory Angina Pectoris	Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Device: Placebo	Phase II

MedlinePlus related topics: Angina

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Medispec:

Primary Outcome Measures:

Total Exercise Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in SPECT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in AP-CCS [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator A - Treatment group. Patients in this group receive actual shockwave therapy.	Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) Energy Density - 0.09 mJ/mm2
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 Placebo

Detailed 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- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662727

Contacts

Contact: David Leibowitz, MD

+972-2-6776564

OLEIBO@hadassah.org.il

Locations

Israel
Hadassah-Hebrew University Medical Center	Recruiting
Jerusalem, Israel
Contact: David Leibowitz, MD +972-2-6776564 OLEIBO@hadassah.org.il
Principal Investigator: David Leibowitz, MD

Sponsors and Collaborators

Medispec

Hadassah-Hebrew University Medical Center

Investigators

Principal Investigator:

David Leibowitz, MD

Hadassah-Hebrew University Medical Center

More Information

Responsible Party:	Hadassah-Hebrew University Medical Center, Cardiology Department ( Dr. David Leibowitz )
Study ID Numbers:	ESMR-RCT-IL
Study First Received:	April 14, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00662727
Health Authority:	Israel: Ethics Commission

Keywords provided by Medispec:

Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009