Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

• Sponsor: Timothy M. Bateman, MD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01919450
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Duration (Months): 33
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Blood Flow Reserve	Drug: Regadenoson; Radiation: Rubidium-82	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 Second Delay A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.	Drug: Regadenoson; Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Lexiscan ; Radiation: Rubidium-82; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Cardio-Gen82
Active Comparator: 2 Minute Delay A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.	Drug: Regadenoson; Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Lexiscan ; Radiation: Rubidium-82; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Cardio-Gen82
Active Comparator: 4 Minute Delay A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.	Drug: Regadenoson; Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Lexiscan ; Radiation: Rubidium-82; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Cardio-Gen82
Active Comparator: 1 Minute Delay A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.	Drug: Regadenoson; Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Lexiscan ; Radiation: Rubidium-82; Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.; Other Names: Cardio-Gen82

Outcome Measures

Primary Outcome Measures

1. Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) [4 minutes]

   The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

2. Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson) [2 mintues]

   The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

3. Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson) [10 seconds]

   The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

4. Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson) [1 minute]

   The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Recent normal clinically-indicated exercise myocardial perfusion SPECT, treadmill maximal exercise test or exercise echocardiographic study

• No change in symptoms between the exercise study and PET study

• Capable of providing written informed consent

• BMI 25-32 kg/m2

Exclusion Criteria:

• Diabetes mellitus

• Coronary Artery Calcium Score >25

• Second and Third Degree Atrioventricular Node Block

• Sinus Node Dysfunction

• Recent Syncope of unknown etiology

• Left ventricular hypertrophy per ECG or echocardiography

• Slowed circulation times

• Active wheezing or with acute asthmatic or bronchospastic attacks requiring changes in therapy within the past 30 days.

• Patients that have experienced a previous hypersensitivity reaction thought to be related to Lexiscan

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Luke's Hospital Imaging Center	Kansas City	Missouri	United States	64111

Sponsors and Collaborators

• Timothy M. Bateman, MD

Investigators

• Principal Investigator: Timothy M Bateman, MD, Cardiovascular Imaging Technologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy M. Bateman, MD, Medical Director, Cardiovascular Imaging Technologies
• ClinicalTrials.gov Identifier: NCT01919450
• Other Study ID Numbers: 13-058
• First Posted: Aug 9, 2013
• Last Update Posted: Aug 16, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Timothy M. Bateman, MD, Medical Director, Cardiovascular Imaging Technologies: PET; Lexiscan; Regadenoson; Rubidium; Blood Flow Reserve; Myocardial Perfusion; Quantitated Myocardial Perfusion
• Additional relevant MeSH terms: Regadenoson

Study Results

Participant Flow

Recruitment Details	Subjects with a low pretest likelihood for CAD based on gender, symptoms and recent (<90 days) normal-clinically-indicated TMET, exercise echocardiogram or exercise myocardial perfusion SPECT test were recruited for consent and participation.

Arm/Group Title	10 Second Delay	2 Minute Delay	4 Minute Delay	1 Minute Delay
Arm/Group Description	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Period Title: Overall Study
STARTED	20	20	20	20
COMPLETED	20	20	20	19
NOT COMPLETED	0	0	0	1

Baseline Characteristics

Arm/Group Title	10 Second Delay	2 Minute Delay	4 Minute Delay	1 Minute Delay	Total
Arm/Group Description	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	Total of all reporting groups
Overall Participants	20	20	20	20	80
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50.5 (13.8)	51.3 (10.4)	53.1 (9.6)	50.6 (9.9)	51.9 (11.0)
Sex: Female, Male (Count of Participants)
Female	14 70%	6 30%	10 50%	15 75%	45 56.3%
Male	6 30%	14 70%	10 50%	5 25%	35 43.8%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	20 100%	20 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)
Description	The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.
Time Frame	4 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	4 Minute Delay
Arm/Group Description	A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Participants	18
Mean (Standard Deviation) [Ratio]	2.57 (0.71)

2. Primary Outcome

Title	Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)
Description	The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.
Time Frame	2 mintues

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 Minute Delay
Arm/Group Description	A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Participants	19
Mean (Standard Deviation) [Ratio]	2.93 (0.7)

3. Primary Outcome

Title	Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)
Description	The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.
Time Frame	10 seconds

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	10 Second Delay
Arm/Group Description	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Participants	19
Median (Standard Deviation) [Ratio]	2.34 (.38)

4. Primary Outcome

Title	Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)
Description	The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.
Time Frame	1 minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Minute Delay
Arm/Group Description	A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Participants	18
Mean (Standard Deviation) [Ratio]	2.76 (.56)

Adverse Events

Time Frame	Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility.
Adverse Event Reporting Description	AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.
Arm/Group Title	10 Second Delay		2 Minute Delay		4 Minute Delay		1 Minute Delay
Arm/Group Description	A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.		A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.		A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.		A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
All Cause Mortality
	10 Second Delay		2 Minute Delay		4 Minute Delay		1 Minute Delay
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	10 Second Delay		2 Minute Delay		4 Minute Delay		1 Minute Delay
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/19 (0%)		1/20 (5%)
Musculoskeletal and connective tissue disorders
Neck Pain	0/20 (0%)	0	0/20 (0%)	0	0/19 (0%)	0	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	10 Second Delay		2 Minute Delay		4 Minute Delay		1 Minute Delay
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/19 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.