Treatment of Refractory Angina Pectoris by Shock Wave Therapy

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universal Research Group
• Collaborator: UNIQUIP INTERNATIONAL, Pakistan
• Treatments: 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.