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Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medispec.
Recruitment status was  Active, not recruiting
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

November 15, 2010
April 1, 2012
January 2008
April 2012   (final data collection date for primary outcome measure)
Change in AP-CCS [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
The AP CCS Stage at the 6 months post baseline.
Same as current
Complete list of historical versions of study NCT01567644 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Angina Pectoris
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
Other Names:
  • Cardiospec
  • ESMR therapy
  • Extracorporeal Shockwave Myocardial Revascularization
Experimental: Active Shockwave Therapy
Patients in this group receive shockwave therapy.
Intervention: Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
September 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01567644
ESMR-NRW-DE
No
Medispec
Medispec
Heart and Diabetes Center North-Rhine Westfalia
Principal Investigator: Lothar Faber, Prof. MD Heart and Diabetes Center North-Rhine Westfalia
Medispec
April 2012

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