Trial Outcomes & Findings for Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR) (NCT NCT01482169)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

DAY 1

Results posted on

2018-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	48
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	2

Baseline Characteristics

Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenoscan + Regadenoson n=46 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adenoscan n=46 Participants Subjects will have the FFR Measurement with IV Adenoscan® FFR Measurement with IV Adenoscan®: 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®.	Regadenoson n=46 Participants Subjects will have the FFR Measurement with IV Regadenson FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.
Comparing Measurement of Fractional Flow Reserve (FFR)	.83 FFR Standard Deviation 0.082	.84 FFR Standard Deviation 0.084

SECONDARY outcome

Timeframe: seconds

Population: Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.

In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection

Outcome measures

Outcome measures
Measure	Adenoscan n=41 Participants Subjects will have the FFR Measurement with IV Adenoscan® FFR Measurement with IV Adenoscan®: 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®.	Regadenoson Subjects will have the FFR Measurement with IV Regadenson FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.
Duration to Baseline Hyperemia After Aminophylline Injection	112 seconds Standard Deviation 72	—

Adverse Events

Adenoscan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regadenson

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Bober

Ochsner Clinic Foundation

Phone: 504-842-4135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place