Coronary artery disease Circulatory System Angina pectoris
Conditions
Interventions
In this study, all participants will receive the same interventions (there is no control group). Each participant will serve as their own control
comparison will be made between their first SPECT and follow-up SPECT.
Efficacy:
1. The patient will be positioned on the treatment table and connected to the ECG moni
Sponsors
UNIQUIP International (Pakistan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1.2. Alleviation of anginal symptoms 1.2. Improved myocardial perfusion 1.3. To determine whether the shock wave therapy serves as an adjuvant therapy for the treatment of refractory angina pectoris 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in cardiac enzymes before and after the first treatment 2. The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model) 3. AP CCS Stage: The AP CCS Stage at 6 months post-baseline, or at the last visit for patients who terminate prematurely 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 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. | — |
Countries
Pakistan
Outcome results
None listed