Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

Refractory Angina Pectoris Clinical Trial

Official title:

Clinical Trial Evaluating the Treatment of Patients With Refractory Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01567592
• Other study ID #: ESMR-KMH-Canada
• Status: Suspended
• Phase: Phase 1
• First received: March 28, 2012
• Last updated: April 1, 2012
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina Pectoris

Intervention

Device:
• Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)
Energy Density - 0.09 mJ/mm2

Locations

Country	Name	City	State
Canada	KMH Cardiology & Diagnostic Centers	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	KMH Cardiology and Diagnostic Centres

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in SPECT	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).	6 months	No
Secondary	Change in AP-CCS	The AP CCS Stage at the 6 months post baseline.	6 months	No
Secondary	Total Exercise time	The change in Total Exercise Time (ETT) from baseline to 6 months post baseline.	6 months	No
Secondary	Number of angina attacks (patient diary)	The change in the number of angina attacks from baseline to 6 months post baseline. The number of attacks per week will be documented.	6 months	No