Overview
Treatment of Refractory Angina Pectoris by Shock Wave Therapy
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine that extracorporeal shock wave therapy (ESWT) is safe and effective for the treatment of refractory angina pectoris.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Universal Research GroupCollaborator:
UNIQUIP INTERNATIONAL, PakistanTreatments:
Antihypertensive Agents
Criteria
Inclusion Criteria:- Male or female, 18 years or older.
- Diagnosis of chronic stable angina pectoris. Diagnosis is based on medical history,
complete physical evaluation, and Exercise Single-Photon Emission Computed Tomography
(Exercise SPECT).
- Patient has documented myocardial segments with reversible ischemia and or
hibernation.
- 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 25% of the first (Patients should not be
informed of exercise restrictions required for entry into the study).
- 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.
- Newly diagnosed type II diabetes.
Exclusion Criteria:
- Chronic lung disease including emphysema and pulmonary fibrosis.
- 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 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 myocardial infarction (MI) less than 3 months prior to treatment.
- Patients who are diagnosed with a 3rd and 4th degree heart valve disease.
- Patient with intraventricular thrombus.
- Pregnancy.
- Patient with a malignancy in the area of treatment.