Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01499316
Status:
UNKNOWN
Last Update Posted:
2014-03-10
First Post:
2011-12-05
Brief Title:
Investigating the Effects of Hyperoxia on Fractional Flow Reserve
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Investigating the Effects of Hyperoxia on Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 surgery2
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 FFR3 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
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 surgery2
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 FFR3 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None