NCT02760394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

April 19, 2016

Last Update Submit

November 18, 2016

Conditions

Ischemic Heart Disease

Keywords

chronic ischemic heart diseasecoronary bypassrefractory stable anginaHBOTreperfusionneoangiogenesismicrovascularmyocardial perfusion

Outcome Measures

Primary Outcomes (1)

  • change in percentile fixed and reversible defects in myocardial perfusion imaging results

    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.

    2 months

Secondary Outcomes (1)

  • change in symptoms using the Seattle Angina Questionnaire

    2 months

Study Arms (2)

Treated group

ACTIVE COMPARATOR

40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.

Device: HBOT

Control group

OTHER

Following 2 months of follow up the group will be crossed over to receive the same treatment as the treated group

Device: HBOT

Interventions

HBOTDEVICE

40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.

Control groupTreated group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaAngina, StableNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMetaplasiaPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 3, 2016

Study Start

July 1, 2014

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)