An interventional study of FFR Measurement with IV Adenoscan® then with Regadenoson in Coronary Artery Disease, sponsored by Ochsner Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-11.
Sponsored by Ochsner Health System · Not applicable, Interventional, and Diagnostic
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 48 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects will have the FFR Measurement with IV Adenoscan®
Drug: FFR Measurement with IV Adenoscan® then with Regadenoson
Subjects will have the FFR Measurement with IV Regadenoson
Drug: 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.
Also known as: Adenoscan® vs Regadenoson
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
Duration to Baseline Hyperemia After Aminophylline Injection
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
Time frame: seconds
| Milestone | Adenoscan + Regadenoson |
|---|---|
| Started | 48 |
| Completed | 46 |
| Not completed | 2 |
| Withdrew: Physician decision | 2 |
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.
| FFR | Adenoscan | Regadenoson |
|---|---|---|
| Comparing Measurement of Fractional Flow Reserve (FFR) | .83 ± 0.082 | .84 ± 0.084 |
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
| seconds | Duration to Baseline Hyperemia After Aminophylline Administrat |
|---|---|
| Duration to Baseline Hyperemia After Aminophylline Injection | 112 ± 72 |
Collected over Subjects were monitored during and post-procedure until discharge from the procedure. This duration was less than 24 hours for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adenoscan | — | 0/48 (0%) | 0/48 (0%) |
| Regadenson | — | 0/48 (0%) | 0/48 (0%) |
| Age, Categorical(Participants) | Adenoscan + Regadenoson |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 20 |
| Age, Continuous(years) | Adenoscan + Regadenoson |
|---|---|
| Median | 61.5 ± 0 |
| Sex: Female, Male(Participants) | Adenoscan + Regadenoson |
|---|---|
| Female | 9 |
| Male | 37 |
| Region of Enrollment(Participants) | Adenoscan + Regadenoson |
|---|---|
| United States | 46 |
Plan to share: No
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Ochsner Health System