Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

This study has suspended participant recruitment.
Sponsor:
Collaborator:
KMH Cardiology and Diagnostic Centres
Information provided by (Responsible Party):
Medispec
ClinicalTrials.gov Identifier:
NCT01567592
First received: March 28, 2012
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 Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Resource links provided by NLM:


Further study details as provided by Medispec:

Primary Outcome Measures:
  • Time to Angina [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in time to angina using the modified Bruce exercise test from baseline to the 6 moths post baseline assessment


Secondary Outcome Measures:
  • Change in SPECT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segments model).

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

  • Total Exercise time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The change in Total Exercise Time (ETT) from baseline to 6 months post baseline.

  • Number of angina attacks (patient diary) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.


Estimated Enrollment: 20
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Shockwave Therapy
Treatment group. Patients in this group receive actual 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- SPECT 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

  1. The patient will have an acoustic window to the myocardium by echocardiography. 4 chamber view (4CH), 2 chamber view (2CH), long axis (LAX) and short axis view (SAX) should be verified.
  2. Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT.
  3. Patient has documented myocardial reversible ischemia and or hibernation in at least one segment.
  4. Patient is classified as AP CCS of III or IV.
  5. Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
  6. Patients demonstrates exercise tolerance time (ETT) duration < 10 minutes on a modified Bruce protocol on 2 consecutive tests (tests no less than 24 hours and no more than 2 weeks apart), with the second test within the difference of 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study).
  7. Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
  8. Patient has refused to undergo another angioplasty or CABG.
  9. Patient has signed an informed consent form.
  10. Patient's condition should be stable and should have a life expectancy of > 12 months.
  11. 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.

Exclusion Criteria

  1. Patient has chronic lung disease based on the GOLD criteria the patient has stage IV: Very Severe COPD according to Spirometric Classification of COPD, Severity based on Post-Bronchodilator
  2. Patient has emphysema and pulmonary fibrosis.
  3. Patient has active endocarditis, myocarditis or pericarditis.
  4. 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 was treated with TMR (Transmyocardial revascularization) or PMR (Percutaneous revascularization) , or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
  5. Patients who are unwilling or unable to cooperate with study procedure.
  6. Patients who are unwilling to quit smoking during the study procedure (including screening phase)
  7. Patients who had MI less than 3 months prior to treatment
  8. Patients with moderately severe or severe valvular disease. Moderately-severe and severe disease will be echographically diagnosed as follows:

    • Aortic Stenosis: Patients with Moderately-severe [Peak Aortic valve gradient (AVG): 50-60 mmHg; Mean AVG: 30-40 mmHg; Effective orifice area (EOA): 0.75-1.0 cm2] and severe Aortic Stenosis [Peak AVG: above 60 mmHg; Mean AVG: above 40 mmHg; EOA: below 0.75 cm2]
    • Mitral Stenosis: Patients with severe Mitral Stenosis [EOA: below 1 cm2; Pressure half-time (ms): above 200 mmHg; Mean Mitral valve gradient: above 10 mmHg]
    • Aortic Regurgitation & Mitral Regurgitation: Patients with moderately- severe and severe aortic regurgitation and mitral regurgitation will be excluded.
    • Moderately-severe (grade 3, or 3/4) and severe (grade 4, or 4/4) are hemodynamically significant.
    • Tricuspid Regurgitation (TR): Its severity is graded from 1-4 as for aortic and mitral regurgitation. Grades 3 and 4 will be excluded from the study. The more severe levels of TR are common in severe biventricular failure, mitral stenosis, cor pulmunale and any other cause of pulmonary hypertension.
  9. Patient with intraventricular thrombus
  10. Patient is pregnant
  11. Patient with a malignancy in the area of treatment
  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: NCT01567592

Locations
Canada
KMH Cardiology & Diagnostic Centers
Ontario, Canada
Sponsors and Collaborators
Medispec
KMH Cardiology and Diagnostic Centres
Investigators
Principal Investigator: Arvi Grover, MD KMH Cardiology & Diagnostic Centers
  More Information

No publications provided

Responsible Party: Medispec
ClinicalTrials.gov Identifier: NCT01567592     History of Changes
Other Study ID Numbers: ESMR-KMH-Canada
Study First Received: March 28, 2012
Last Updated: April 1, 2012
Health Authority: Canada: Ethics Review Committee

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 29, 2014