Trial Outcomes & Findings for Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR) (NCT NCT00763035)

Results Overview

To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

14 participants

Primary outcome timeframe

1 day

Results posted on

2018-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator: A: Dobutamine Test Then Regadenoson Test Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.	Active Comparator: B Regadenoson Test Then Dobutamine Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
First Intervention STARTED	10	4
First Intervention COMPLETED	9	3
First Intervention NOT COMPLETED	1	1
Second Intervention STARTED	9	3
Second Intervention COMPLETED	6	3
Second Intervention NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Comparator: A: Dobutamine Test Then Regadenoson Test Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.	Active Comparator: B Regadenoson Test Then Dobutamine Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
First Intervention Did not meeting inclusion/exclusion	1	0
First Intervention Adverse Event	0	1
Second Intervention Adverse Event	1	0
Second Intervention Physician Decision	2	0

Baseline Characteristics

Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Sample n=14 Participants Overall Study Sample
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Duration of Procedures	48 Minutes Interval 35.0 to 75.0	55 Minutes Interval 28.0 to 138.0

SECONDARY outcome

Timeframe: 1 day

The Compare MD tool have the following scales: Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(\>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure (1 very Difficult to 5 very easy), higher scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Ease of administration	2.9 units on a scale Interval 1.0 to 4.0	1.9 units on a scale Interval 1.0 to 3.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Patient Comfort	1.8 units on a scale Interval 1.0 to 3.0	1.5 units on a scale Interval 1.0 to 3.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Interruptions during the procedure	0.5 units on a scale Interval 0.0 to 1.0	0.1 units on a scale Interval 0.0 to 1.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Side effects	2.3 units on a scale Interval 1.0 to 3.0	1.6 units on a scale Interval 1.0 to 2.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Level of anxiety while during the procedure	2.4 units on a scale Interval 1.0 to 3.0	1.5 units on a scale Interval 1.0 to 3.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire Overall rating of the procedure	4.3 units on a scale Interval 2.0 to 5.0	4.1 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 1 day

Ease of Administration of regadenoson versus intravenous dobutamine using Compare MD Questionnaire. Episodes of arrhythmias (including PVCs) and bradycardia (HR\<60), low score represent better outcome. Number of Episodes of wheezing and SPO2\<94%, low numbers represent better outcome.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) Episodes of arrhythmias and bradycardia	0.6 number of episodes Interval 0.0 to 4.0	0.1 number of episodes Interval 0.0 to 1.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) Episodes of wheezing and SPO2<94%	0.0 number of episodes Interval 0.0 to 0.0	0.0 number of episodes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 1 day

To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(\>6), low score represent better outcome. Level of monitoring - Scale from 1(most easy among all MRI tests) to 4(most difficult), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure - Scale from 1(very difficult) to 4(very easy), higher scores represent better outcome.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire Patient Comfort	1.2 units on a scale Interval 0.0 to 3.0	1.5 units on a scale Interval 1.0 to 3.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire Interruptions during the procedure	0.6 units on a scale Interval 0.0 to 2.0	0.1 units on a scale Interval 0.0 to 1.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire Level of monitoring	2.7 units on a scale Interval 1.0 to 4.0	1.1 units on a scale Interval 0.0 to 2.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire Level of anxiety while during the procedure	1.8 units on a scale Interval 1.0 to 3.0	1.3 units on a scale Interval 0.0 to 2.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire Overall rating of the procedure	3.5 units on a scale Interval 2.0 to 5.0	4.3 units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 1 day

To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Low scores represent better outcome.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)	.2 number of episodes Interval 0.0 to 1.0	0.0 number of episodes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 1 day

To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(\>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire Ease of administration	3.4 units on a scale Interval 2.0 to 5.0	1.5 units on a scale Interval 1.0 to 2.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire Patient Comfort	2.3 units on a scale Interval 1.0 to 4.0	1.5 units on a scale Interval 1.0 to 2.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire Interruptions during the procedure	0.6 units on a scale Interval 0.0 to 2.0	0.1 units on a scale Interval 0.0 to 1.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire Side effects	2.0 units on a scale Interval 1.0 to 3.0	1.3 units on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 1 day

To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Episodes of (SBP\>140), low number represent better outcome. Episodes of arrhythmias (including PVCs) and bradycardia (HR\<60), low number represent better outcome. Episodes of wheezing and SPO2\<94%, low number represent better outcome.

Outcome measures

Outcome measures
Measure	Dobutamine n=12 Participants All participants that completed Dobutamine testing	Regadenoson n=9 Participants All participants that completed the regadenoson testing
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) Episodes of hypertension	1.6 number of episodes Interval 0.0 to 7.0	2 number of episodes Interval 0.0 to 8.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) Episodes of arrhythmias and bradycardia	.8 number of episodes Interval 0.0 to 4.0	.8 number of episodes Interval 0.0 to 4.0
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) Episodes of wheezing and SPO2<94%	0.0 number of episodes Interval 0.0 to 0.0	0.0 number of episodes Interval 0.0 to 0.0

Adverse Events

Dobutamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regadenoson

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dobutamine n=9 participants at risk All participants that completed Dobutamine testing	Regadenoson n=3 participants at risk All participants that completed the regadenoson testing
Nervous system disorders Headache	0.00% 0/9	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Abdominal Complaints	0.00% 0/9	33.3% 1/3 • Number of events 1

Additional Information

Gregory Hundley

Wake Forest University Health Sciences

Phone: +1 (336) 716-0607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place