Treatment of refractory angina pectoris by shock wave therapy
- Conditions
- Coronary artery diseaseCirculatory SystemAngina pectoris
- Registration Number
- ISRCTN68966125
- Lead Sponsor
- IQUIP International (Pakistan)
- Brief Summary
2012 results in: https://europepmc.org/abstract/med/23011412 (added 20/02/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Male or female, 18 years or older.
2. Diagnosis of chronic stable angina pectoris. Diagnosis is based on medical history, complete physical evaluation, and Exercise Single-Photon Emission Computed Tomography (Exercise SPECT).
3. Patient has documented myocardial segments with reversible ischemia and or hibernation.
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 25% of the first (Patients should not be informed of exercise restrictions required for entry into the study).
7. Patient has refused to undergo another angioplasty or CABG.
8. Patient has signed an informed consent form.
9. Patient's condition should be stable and should have a life expectancy of >12 months.
10. 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.
11. Newly diagnosed type II diabetes.
1. Chronic lung disease including emphysema and pulmonary fibrosis.
2. Active endocarditis, myocarditis or pericarditis.
3. Patient is simultaneously participating in another device or drug study, or has participated in any
4. Clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, 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 myocardial infarction (MI) less than 3 months prior to treatment.
8. Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
9. Patient with intraventricular thrombus.
10. Pregnancy.
11. Patient with a malignancy in the area of treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Therapeutic effect. The following will be assessed at baseline and 6 months post baseline or at the last visit for patients who terminate prematurely:<br> 1.2. Alleviation of anginal symptoms<br> 1.2. Improved myocardial perfusion<br> 1.3. To determine whether the shock wave therapy serves as an adjuvant therapy for the treatment of refractory angina pectoris<br><br> 2. Change in maximal stress exercise capacity testing. The change in total exercise time assessed using the modified Bruce exercise test, from baseline to 6 months post-baseline, or to the last visit for patients who terminate prematurely.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Change in cardiac enzymes before and after the first treatment<br> 2. The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model)<br> 3. AP CCS Stage: The AP CCS Stage at 6 months post-baseline, or at the last visit for patients who terminate prematurely<br> 4. The change in the number of angina attacks from baseline to 6 months post-baseline. The number of attacks per week will be documented<br> 5. Hospital Admission Rate: The change in the number of hospital admission from baseline to 6 months post-baseline. The number of admissions per month will be documented.<br>