Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT00776568
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00776568
Study Brief:
Protocol Section:
NCT00776568