Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

NCT01567592 | Suspended Phase 1

• 1 other identifier: ESMR-KMH-Canada
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Angina Pectoris

Keywords

Extracorporeal Shockwave Therapy; Myocardial Ischemia; Refractory 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 moths 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)

Active Shockwave Therapy

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

Active Shockwave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient is diagnosed with chronic angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise SPECT.
• Patient has documented myocardial reversible ischemia and or hibernation in at least one segment.
• Patient is classified as AP CCS of III or IV.
• Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
• 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).
• Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
• Patient has refused to undergo another angioplasty or CABG.
• Patient has signed an 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 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
• Patient has 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 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.
• Patients who are unwilling or unable to cooperate with study procedure.
• Patients who are unwilling to quit smoking during the study procedure (including screening phase)
• Patients who had MI less than 3 months prior to treatment
• 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.
• Patient with intraventricular thrombus
• Patient is pregnant

Sponsors & Collaborators

• Medispec: lead
• KMH Cardiology and Diagnostic Centres: collaborator

Study Sites (1)

KMH Cardiology & Diagnostic Centers

Ontario, Canada

Location

MeSH Terms

Conditions

Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arvi Grover, MD

  KMH Cardiology & Diagnostic Centers

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

CA (1)