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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01499316

Registration number

NCT01499316

Ethics application status

Date submitted

5/12/2011

Date registered

26/12/2011

Date last updated

10/03/2014

Titles & IDs

Public title

Investigating the Effects of Hyperoxia on Fractional Flow Reserve

Scientific title

Investigating the Effects of Hyperoxia on Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease

Secondary ID [1]

426/11

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Coronary Artery Disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Other cardiovascular diseases

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Surgery - High Flow oxygen
Treatment: Surgery - Room Air

Experimental: High Flow oxygen - 10 minute of 10/L min of inhaled oxygen with reservoir bag.

Experimental: Room Air -

Treatment: Surgery: High Flow oxygen
10 minute shigh flow oxygen

Treatment: Surgery: Room Air
Room air breathing

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Fractional flow reserve

Timepoint [1]

Duration of inpatient stay 2-3 days

Secondary outcome [1]

index of micro-vascular resistance

Timepoint [1]

Duration of inpatient stay 2-3 days

Eligibility

Key inclusion criteria

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

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Other

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/03/2014

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/12/2014

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

Summary

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 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.

Trial website

https://clinicaltrials.gov/study/NCT01499316

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01499316

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01499316