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Hyperbaric Oxygen Therapy in Patients With Chronic Stable Ischemic Heart Disease: An Option for Therapeutic Angiogenesis?

Unknown statusNot applicableNCT02760394
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Hyperbaric oxygen therapy (HBOT) is proposed as a possible in vivo angiogenic stimulator for improving microvascular myocardial perfusion and anginal symptoms as assessed by myocardial perfusion imaging and angina questionnaire in patients with chronic stable ischemic heart disease, when no other means to relief symptoms and/or ischemia are available.

Study details

Official title
Hyperbaric Oxygen Therapy in Patients With Chronic Stable Ischemic Heart Disease: An Option for Therapeutic Angiogenesis?
Interventions
  • Device: HBOT
Sponsor
Assaf Harofeh MC
Organization
Assaf-Harofeh Medical Center
Start date
2014-07
Primary completion
2017-06
Sex
All
Age range
from 21 Years
Results posted
No results posted in this snapshot
Countries
Israel
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02760394