Coronary Artery Disease
Conditions
Keywords
Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson
Brief 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.
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.
Interventions
DRUGFFR Measurement with IV Adenoscan® then with 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.
Sponsors
Astellas Pharma Global Development, Inc.
Ochsner Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective left heart catheterization * Age ≥ 18 years (female not of child bearing potential) * Able to provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Measurement of Fractional Flow Reserve (FFR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration to Baseline Hyperemia After Aminophylline Injection | seconds | In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adenoscan + Regadenoson Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson
FFR Measurement with IV Adenoscan® then with 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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Adenoscan + Regadenoson |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 61.5 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 46 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
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.
Time frame: DAY 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adenoscan | Comparing Measurement of Fractional Flow Reserve (FFR) | .83 FFR | Standard Deviation 0.082 |
| Regadenoson | Comparing Measurement of Fractional Flow Reserve (FFR) | .84 FFR | Standard Deviation 0.084 |
Secondary
Duration to Baseline Hyperemia After Aminophylline Injection
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
Time frame: seconds
Population: Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adenoscan | Duration to Baseline Hyperemia After Aminophylline Injection | 112 seconds | Standard Deviation 72 |