Investigating the Effects of Hyperoxia on Fractional Flow Reserve

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Bayside Health
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT01499316
First received: December 5, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Coronary artery disease (CAD) is a condition which refers to the narrowing of the small blood vessels that supplies blood and oxygen to the heart. It is a common cause of chest-pain related symptoms and as a result of a 'heart attack'. In most cases, to assess the severity of the disease is to use coronary angiography, which is a medical imaging technique that uses contrast (a dye) and x-ray to show the blood-flow supply of the coronary arteries.

The optimal treatment for patients with symptomatic coronary disease is aggressive medical therapy. Current guidelines recommend patients with symptomatic CAD and severe disease on angiography undergo revascularisation therapy, which aims to restore blood flow to blocked arteries. This can be done by either percutaneous coronary intervention (feeding a small balloon or other device on a thin tube through blood vessels to the point of blockage and then inflate the balloon to open the artery), or coronary artery bypass grafting (open-heart surgery)2.

For many symptomatic patients who have only moderate disease on angiography, further functional testing is required to assess the extent of the blockage. This can be achieved by placing a pressure wire to the artery of interest, to determine the likelihood that the blockage impedes oxygen delivery to the heart muscle, known as the Fractional Flow Reserve (FFR)3. FFR is commonly performed at the Alfred hospital in the assessment of such patients. During an FFR procedure, further information regarding the health of the small arteries of the heart can be obtained with the calculation of the index of micro-vascular resistance (IMR),

Giving oxygen to patients with CAD is a common clinical practice, especially to all patients in the catheterisation laboratory whose had a 'heart attack' and often administered concurrently with light sedation during elective procedures.

Recently, however, the safety of routine supplemental oxygen in patients with CAD has been questioned5. A research study analysed the outcomes of three small randomised studies on oxygen in patients who experienced a 'heart attack', while suggestive of harm, the findings of the study remain inconclusive.

There may also be deleterious effects of supplemental oxygen, on more stable patients with CAD, who are not experiencing a 'heart attack'. Supplemental oxygen administered in the catheterisation laboratory to patients with stable CAD, has been shown to significantly reduce coronary artery blood flow and increase its resistance6-8. It has also been shown to reduce cardiac output and effect the relaxation phase of the heart cycle. Based on this data it is hypothesised that supplemental oxygen may affect FFR in patients with moderate CAD. The investigators therefore propose to undertake a study of the effects of supplemental oxygen on FFR in patients with moderate CAD.

The patients enrolled into the study will be scheduled for an elective normal contrast diagnostic or interventional procedure as part of their clinically-indicated care. Once a moderate blockage of the artery has been identified, FFR and IMR will be measured. During the first phase of the FFR study, the patient will breathe room air and have a blood test to measure their oxygen level (blood gas). There is a 3 minute washout period, followed by the second phase, whereby the patient will be given 100% oxygen for 10 minutes and have another blood gas measured.

The study will be conducted at Alfred Hospital with a total enrollment of 18 subjects. The estimated time to complete enrollment is 6-10 months.

Data collected on each patient will include demographics, medical history, vital signs (heart rate, blood pressure, height, and weight), usage of cardiovascular medications, pathology results and procedural records. Any adverse events or serious adverse events related to the study procedure will also be recorded.


Condition Intervention
Coronary Artery Disease
Procedure: High Flow oxygen
Procedure: Room Air

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Investigating the Effects of Hyperoxia on Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Fractional flow reserve [ Time Frame: Duration of inpatient stay 2-3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • index of micro-vascular resistance [ Time Frame: Duration of inpatient stay 2-3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Flow oxygen
10 minute of 10/L min of inhaled oxygen with reservoir bag.
Procedure: High Flow oxygen
10 minute shigh flow oxygen
Experimental: Room Air Procedure: Room Air
Room air breathing

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age, AND
  • Undergoing elective coronary angiography
  • Evidence of moderate (40%-79%) stenosis, requiring further routine assessment with FFR.

Exclusion Criteria:

  • Acute coronary syndrome
  • Hypoxia with oxygen saturation measured on pulse oximeter < 94% with the patient breathing air
  • Altered conscious state
  • Evidence of left ventricular failure or cardiogenic shock
  • Unable to perform consent prior to procedure
  • Known hypersensitivity to adenosine
  • Sick sinus syndrome, second or third degree atrioventricular (A-V) block (except in patients with a functioning artificial pacemaker).
  • Chronic Obstructive lung disease COPD or asthma
  • Long QT syndrome
  • Severe hypotension
  • Concomitant use of dipyridamole
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499316

Locations
Australia, Victoria
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: David M Kaye, MBBS PhD         
Sub-Investigator: James Shaw, MBBS Phd         
Sub-Investigator: Stephen Duffy, MBBS PhD         
Sub-Investigator: Dion Stub, MBBS         
Sponsors and Collaborators
Bayside Health
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT01499316     History of Changes
Other Study ID Numbers: 426/11
Study First Received: December 5, 2011
Last Updated: March 6, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Coronary artery disease
Fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperoxia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014