Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Heart and Diabetes Center North-Rhine Westfalia

Information provided by (Responsible Party):

Medispec

ClinicalTrials.gov Identifier:

NCT01567644

First received: November 15, 2010

Last updated: April 1, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2010

Last Updated Date

April 1, 2012

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

The AP CCS Stage at the 6 months post baseline.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01567644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Exercise tolerance time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
Change in PET scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Official Title ^ICMJE

Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

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.

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- PET 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Refractory Angina Pectoris

Intervention ^ICMJE

Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Energy Density - 0.09 mJ/mm2

Other Names:

Cardiospec
ESMR therapy
Extracorporeal Shockwave Myocardial Revascularization

Study Arm (s)

Experimental: Active Shockwave Therapy

Patients in this group receive shockwave therapy.

Intervention: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01567644

Other Study ID Numbers ^ICMJE

ESMR-NRW-DE

Has Data Monitoring Committee

Responsible Party

Medispec

Study Sponsor ^ICMJE

Medispec

Collaborators ^ICMJE

Heart and Diabetes Center North-Rhine Westfalia

Investigators ^ICMJE

Principal Investigator:

Lothar Faber, Prof. MD

Heart and Diabetes Center North-Rhine Westfalia

Information Provided By

Medispec

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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