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

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ClinicalTrials.gov Identifier: NCT02760394
Recruitment Status : Unknown
Verified November 2016 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Device: HBOT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy in Patients With Chronic Stable Ischemic Heart Disease: An Option for Therapeutic Angiogenesis?
Study Start Date : July 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

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Arm Intervention/treatment
Active Comparator: Treated group
40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.
Device: HBOT
40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.

Control group
Following 2 months of follow up the group will be crossed over to receive the same treatment as the treated group
Device: HBOT
40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.




Primary Outcome Measures :
  1. change in percentile fixed and reversible defects in myocardial perfusion imaging results [ Time Frame: 2 months ]
    The myocardial perfusion images will be analyzed at baseline and at the end of treatment and control periods to include both percentile of fixed defects and percentile of reversible defects. The images will undergo computerized processing in order for the pre-post images to be comparable.


Secondary Outcome Measures :
  1. change in symptoms using the Seattle Angina Questionnaire [ Time Frame: 2 months ]
    Symptoms will be evaluated using the Seattle Angina Questionnaire during baseline and following control and treatment periods.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760394


Locations
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Israel
Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Shai efrati, MD    972-549-212-866    efratishai@013.net   
Sponsors and Collaborators
Assaf Harofeh MC

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Responsible Party: Assaf Harofeh MC, Medical Doctor, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02760394     History of Changes
Other Study ID Numbers: 0165-15-ASF
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
chronic ischemic heart disease
coronary bypass
refractory stable angina
HBOT
reperfusion
neoangiogenesis
microvascular
myocardial perfusion

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases