Trial Outcomes & Findings for Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress (NCT NCT01370265)
NCT ID: NCT01370265
Last Updated: 2013-09-05
Results Overview
MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4). The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit.
COMPLETED
NA
12 participants
Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
2013-09-05
Participant Flow
From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.
Participant milestones
| Measure |
Regadenoson, Then Adenosine
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
Adenosine, Then Regadenoson
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
|
|---|---|---|
|
Resting Myocardial Blood Flow (MBF)
STARTED
|
6
|
6
|
|
Resting Myocardial Blood Flow (MBF)
COMPLETED
|
6
|
6
|
|
Resting Myocardial Blood Flow (MBF)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (50-minute Period Decay)
STARTED
|
5
|
5
|
|
Washout Period (50-minute Period Decay)
COMPLETED
|
5
|
5
|
|
Washout Period (50-minute Period Decay)
NOT COMPLETED
|
0
|
0
|
|
First Intervention
STARTED
|
6
|
6
|
|
First Intervention
COMPLETED
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
5
|
5
|
|
Second Intervention
COMPLETED
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regadenoson, Then Adenosine
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
Adenosine, Then Regadenoson
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
1
|
Baseline Characteristics
Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=12 Participants
Includes groups randomized to receive Regadenoson first and Adenosine first.
|
|---|---|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Body Mass Index
|
26.1 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unitPopulation: Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4). The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Global Hyperemic Myocardial Blood Flow (MBF)
|
3.1 mL/min/gm
Standard Deviation 1.4
|
3.1 mL/min/gm
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unitPopulation: Resting MBF was measured on all subjects prior to the interventions.
MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4). Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Resting Global MBF and Resting Segmental MBF
Resting Global MBF
|
0.8 ml/min/gm
Standard Deviation 0.2
|
—
|
|
Resting Global MBF and Resting Segmental MBF
Resting Anterior MBF
|
0.7 ml/min/gm
Standard Deviation 0.2
|
—
|
|
Resting Global MBF and Resting Segmental MBF
Resting Septum MBF
|
0.9 ml/min/gm
Standard Deviation 0.2
|
—
|
|
Resting Global MBF and Resting Segmental MBF
Resting Inferior MBF
|
0.8 ml/min/gm
Standard Deviation 0.2
|
—
|
|
Resting Global MBF and Resting Segmental MBF
Resting Lateral MBF
|
0.8 ml/min/gm
Standard Deviation 0.2
|
—
|
SECONDARY outcome
Timeframe: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unitPopulation: Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Global Cardiac Flow Rate
|
3.8 ratio
Standard Deviation 1.5
|
4.0 ratio
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unitPopulation: Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes. The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Hyperemic Segmental MBF
Hyperemic MBF Anterior
|
2.5 mL/min/gm
Standard Deviation 0.5
|
2.6 mL/min/gm
Standard Deviation 0.8
|
|
Hyperemic Segmental MBF
Hyperemic MBF Septum
|
3.1 mL/min/gm
Standard Deviation 0.8
|
3.2 mL/min/gm
Standard Deviation 1.4
|
|
Hyperemic Segmental MBF
Hyperemic MBF Inferior
|
3.5 mL/min/gm
Standard Deviation 1.6
|
3.6 mL/min/gm
Standard Deviation 1.3
|
|
Hyperemic Segmental MBF
Hyperemic MBF Lateral
|
2.9 mL/min/gm
Standard Deviation 0.6
|
2.9 mL/min/gm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unitPopulation: Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
CFR was calculated using the equation: hyperemic MBF/resting MBF.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Segmental CFR
CFR Anterior
|
3.4 ratio
Standard Deviation 1.1
|
3.7 ratio
Standard Deviation 1.0
|
|
Segmental CFR
CFR Septum
|
3.5 ratio
Standard Deviation 0.7
|
3.6 ratio
Standard Deviation 1.6
|
|
Segmental CFR
CFR Inferior
|
4.4 ratio
Standard Deviation 1.4
|
4.6 ratio
Standard Deviation 1.3
|
|
Segmental CFR
CFR Lateral
|
3.9 ratio
Standard Deviation 1.0
|
4.0 ratio
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unitPopulation: Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Heart Rate (Beats Per Minute (BPM))
Resting heart rate
|
62 bpm
Standard Deviation 10
|
60 bpm
Standard Deviation 9
|
|
Heart Rate (Beats Per Minute (BPM))
Hyperemic heart rate
|
98 bpm
Standard Deviation 16
|
93 bpm
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Day 2, approximately 4 hours after arrival in the PET unitPopulation: Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
Outcome measures
| Measure |
Regadenoson
n=10 Participants
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=10 Participants
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Hyperemic Blood Pressure (mmHg)
Systolic
|
130 mmHg
Standard Deviation 17
|
132 mmHg
Standard Deviation 23
|
|
Hyperemic Blood Pressure (mmHg)
Diastolic
|
72 mmHg
Standard Deviation 11
|
75 mmHg
Standard Deviation 17
|
Adverse Events
Regadenoson
Adenosine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regadenoson
n=12 participants at risk
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
|
Adenosine
n=12 participants at risk
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
|
|---|---|---|
|
Cardiac disorders
Ischemic ECG findings
|
8.3%
1/12 • Number of events 1 • Subjects were monitored for adverse events for the time while on study, approximately 4 weeks.
|
8.3%
1/12 • Number of events 1 • Subjects were monitored for adverse events for the time while on study, approximately 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place