NCT01219218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

October 10, 2010

Last Update Submit

February 17, 2013

Conditions

Refractory Angina Pectoris

Keywords

Extracorporeal Shockwave TherapyMyocardial IschemiaRefractory Angina

Outcome Measures

Primary Outcomes (1)

  • Time to Angina

    Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment

    6 months

Secondary Outcomes (4)

  • Change in SPECT

    6 months

  • Change in AP-CCS

    6 months

  • Total Exercise time

    6 months

  • Number of Angina attacks (patient diary)

    6 months

Study Arms (1)

A

EXPERIMENTAL

Treatment group. Patients in this group receive actual shockwave therapy.

Device: Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)

Interventions

Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)DEVICE

Energy Density - 0.09 mJ/mm2

Also known as: Cardiospec, ESMR therapy, Extracorporeal Shockwave Myocardial Revascularization
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. Diagnosis is based on medical history, complete physical evaluation.
  • Patient has documented myocardial segments with reversible ischemia.
  • Patient is classified in AP CCS of III-IV.
  • Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
  • Patient demonstrates exercise tolerance capacity of no higher than 125 W on a modified Bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, ST-depression).
  • Patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two).
  • Patient has documented epicardial coronary artery disease not amenable to angioplasty or CABG.
  • Patient has signed an IRB approved informed consent form.
  • Patient's condition should be stable and should have a life expectancy of \>12 months. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion.

You may not qualify if:

  • Patient is pregnant
  • Patient has chronic lung disease including emphysema and pulmonary fibrosis.
  • Patient has active endocarditis, myocarditis or pericarditis.
  • Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any ESWT machine of a competitor company within 3 months of entry into the study.
  • Patients who are unwilling or unable to cooperate with study procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Angina PectorisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Johannes Waltenberger, MD, PhD

    Academisch Ziekenhuis Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2010

First Posted

October 13, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

NL(1)