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Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Primary Purpose

Refractory Angina Pectoris

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Sponsored by
Medispec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Angina Pectoris focused on measuring Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart and Diabetes Center North-Rhine Westfalia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Shockwave Therapy

Arm Description

Patients in this group receive shockwave therapy.

Outcomes

Primary Outcome Measures

Change in AP-CCS
The AP CCS Stage at the 6 months post baseline.

Secondary Outcome Measures

Exercise tolerance time
The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
Change in PET scan
The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.

Full Information

First Posted
November 15, 2010
Last Updated
April 1, 2012
Sponsor
Medispec
Collaborators
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT01567644
Brief Title
Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
Official Title
Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medispec
Collaborators
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina Pectoris
Keywords
Extracorporeal Shockwave Therapy, Myocardial Ischemia, Refractory Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Shockwave Therapy
Arm Type
Experimental
Arm Description
Patients in this group receive shockwave therapy.
Intervention Type
Device
Intervention Name(s)
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Other Intervention Name(s)
Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization
Intervention Description
Energy Density - 0.09 mJ/mm2
Primary Outcome Measure Information:
Title
Change in AP-CCS
Description
The AP CCS Stage at the 6 months post baseline.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Exercise tolerance time
Description
The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline
Time Frame
6 Months
Title
Change in PET scan
Description
The change in perfusion in pharmacological induced stress PET scan (at rest and at stress) from baseline to 6 months post baseline.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lothar Faber, Prof. MD
Organizational Affiliation
Heart and Diabetes Center North-Rhine Westfalia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart and Diabetes Center North-Rhine Westfalia
City
Bad Oeynhausen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

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