Coronary Artery DiseaseNCT01482169
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
A study testing FFR Measurement with IV Adenoscan® then with Regadenoson in people with Coronary Artery Disease, run by Ochsner Health System at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR Measurement with IV Adenoscan® then with Regadenoson
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective left heart catheterization
- Age ≥ 18 years (female not of child bearing potential)
- Able to provide written informed consent
Who cannot join
- Contraindications to administration of either Adenoscan® or Regadenoson
- High degree AV block, sick sinus syndrome without a functioning pacemaker
- Symptomatic bradycardia
- Recent STEMI (< 5 days)
- Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
- Dipyridamole use within 24 hours
- Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
- Known severe bronchoconstrictive lung disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Official title: Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
Read the detailed description
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR Measurement with IV Adenoscan® then with Regadenoson
- Keywords
- Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR Measurement with IV Adenoscan® then with RegadenosonDrug
Also called Adenoscan® vs Regadenoson
Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.
| Study group | Role | What they receive |
|---|---|---|
| Adenoscan | Active comparator | Subjects will have the FFR Measurement with IV Adenoscan® Receives: Drug: FFR Measurement with IV Adenoscan® then with Regadenoson |
| Regadenoson | Experimental | Subjects will have the FFR Measurement with IV Regadenoson Receives: Drug: FFR Measurement with IV Adenoscan® then with Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Measurement of Fractional Flow Reserve (FFR)
For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.
Measured: DAY 1
Secondary outcomes (1)
Duration to Baseline Hyperemia After Aminophylline Injection
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
Measured: seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Global Development, Inc.
- Responsible party
- Principal investigator, Robert Bober, M.D., Ochsner Health System
- Investigators
- Robert Bober, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482169
- Sponsor's protocol ID
- 10012012
- Status last verified
- May 2018
- First submitted
- 15 Nov 2011
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
- ClinicalTrials.gov ID
- NCT01482169
- Acronym / sponsor ID
- 10012012
- Conditions
- Coronary Artery Disease
- Keywords
- Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- Astellas Pharma Global Development, Inc.
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
Detailed description
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenoscan | Active comparator | Drug: FFR Measurement with IV Adenoscan® then with RegadenosonSubjects will have the FFR Measurement with IV Adenoscan® |
| Regadenoson | Experimental | Drug: FFR Measurement with IV Adenoscan® then with RegadenosonSubjects will have the FFR Measurement with IV Regadenoson |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective left heart catheterization
- Age ≥ 18 years (female not of child bearing potential)
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- Contraindications to administration of either Adenoscan® or Regadenoson
- High degree AV block, sick sinus syndrome without a functioning pacemaker
- Symptomatic bradycardia
- Recent STEMI (< 5 days)
- Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR Measurement with IV Adenoscan® then with RegadenosonAlso: Adenoscan® vs RegadenosonTesting will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny. | Drug | Adenoscan, Regadenoson |
Primary outcome
Comparing Measurement of Fractional Flow Reserve (FFR)
Time frame: DAY 1
For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.
1 secondary outcome
Duration to Baseline Hyperemia After Aminophylline Injection
Time frame: seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bober, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR Measurement with IV Adenoscan® then with Regadenoson in people with Coronary Artery Disease, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Measurement of Fractional Flow Reserve (FFR) (time frame: DAY 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.