Extracorporeal Shockwave Therapy for the Treatment of Ref... | NCT01567644

Studies
Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

NCT01567644

Sponsor

Medispec

Status

Unknown status

Last Update Posted

Apr 3, 2012Estimated

Enrollment

35Estimated

Phase

Phase 1

Conditions

Refractory Angina Pectoris

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Apr 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Mar 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Name	Class
Heart and Diabetes Center North-Rhine Westfalia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Shockwave Therapy	Experimental	Patients in this group receive shockwave therapy.	Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)	Device	Energy Density - 0.09 mJ/mm2	Active Shockwave Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in AP-CCS	The AP CCS Stage at the 6 months post baseline.	6 Months

Secondary Outcomes

Measure	Description	Time Frame
Exercise tolerance time	The change in Total Exercise Time (Exercise Tolerance Test-ETT) from baseline to 6 months post baseline	6 Months
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lothar Faber, Prof. MD	Heart and Diabetes Center North-Rhine Westfalia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart and Diabetes Center North-Rhine Westfalia		Bad Oeynhausen			Germany

Condition Browse Module

MeSH Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D002637	Chest Pain

Browse Leaves

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Browse Branches

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