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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT01361659
Eligibility Criteria:
Inclusion Criteria:
* Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
* Patients demonstrates exercise tolerance test (ETT) duration \< 10 minutes on a modified Bruce protocol
* No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
* Patient's conditions stable for at least 3 months
* Life expectancy of \> 12 months.
Exclusion Criteria:
* Unstable angina pectoris
* Haemodynamically significant valvular heart disease
* Myocardial infarction \<3 month prior randomization
* Evidence of intracardiac thrombus
* Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
* 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 Extracorporeal Shock Wave Therapy (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 the study procedure.
* Age \< 18 years
* Cardiac or pulmonary malignancy
* No informed consent
* Known depression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01361659
Study Brief:
Protocol Section:
NCT01361659