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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02760394
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years or older.
* Symptomatic or asymptomatic chronic ischemic heart disease patients, with no more than moderate systolic dysfunction (EF\>30%) on optimal medical treatment who have been evaluated for myocardial ischemia using myocardial perfusion study and coronary angiography.
* Patients who demonstrate significant myocardial perfusion defect, defined as ≥5% global perfusion defect and/or ≥3 segments with perfusion defect out of 17 myocardial segments, and were found to have coronary artery disease not amenable for PCI or CABG (or re-CABG) due to anatomical or medical considerations.
* Clinical stable patients in the 3 months before randomization. Good functional class as determinate by the New York Heart association functional status I-III and Canadian Cardiovascular Society Angina class I-III. Optimal medical therapy defined by chronic regular use of a combination of more than 3 antianginal medications (beta blockers, calcium channel blockers, nitrates, unless contraindicated for any reason) and/or secondary prevention drugs (aspirin, aldosterone antagonists, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, statins, unless contraindicated for any reason).
Exclusion Criteria:
* Current smokers or smoking patients who could not comply with the demand to cease smoking prior to inclusion.
* Had been treated with HBOT for any other reasons prior to their inclusion
* Have any other indication for HBOT;
* Chest pathology incompatible with pressure changes;
* Inner ear disease;
* Patients suffering from claustrophobia;
* Inability to sign written informed consent.
* Patients unable to perform exercise tolerance test for any reason
* Hospital admission due to acute coronary syndrome or congestive heart failure exacerbation in the past 3 month before randomization
* r CCS class IV angina
* Patients currently in NYHA functional class IV
* Severe or uncontrolled other medical illness as advanced liver, kidney or oncologic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02760394
Study Brief:
Protocol Section:
NCT02760394