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
  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)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Resource links provided by NLM:


Further study details as provided by Medispec:

Primary Outcome Measures:
  • Change in AP-CCS [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The AP CCS Stage at the 6 months post baseline.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 35
Study Start Date: January 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Shockwave Therapy
Patients in this group receive shockwave therapy.
Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2
Other Names:
  • Cardiospec
  • ESMR therapy
  • Extracorporeal Shockwave Myocardial Revascularization

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567644

Locations
Germany
Heart and Diabetes Center North-Rhine Westfalia
Bad Oeynhausen, Germany
Sponsors and Collaborators
Medispec
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Principal Investigator: Lothar Faber, Prof. MD Heart and Diabetes Center North-Rhine Westfalia
  More Information

No publications provided

Responsible Party: Medispec
ClinicalTrials.gov Identifier: NCT01567644     History of Changes
Other Study ID Numbers: ESMR-NRW-DE
Study First Received: November 15, 2010
Last Updated: April 1, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Medispec:
Extracorporeal Shockwave Therapy
Myocardial Ischemia
Refractory Angina

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014