Trial Outcomes & Findings for Regadenoson R-T Perfusion Imaging Trial (NCT NCT00837369)

NCT ID: NCT00837369

Last Updated: 2024-12-27

Results Overview

Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 hour observation post perfusion
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	Regadenoson 400 ug IV Bolus Injection Real time perfusion (RTPE) studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. Regadenoson: 400ug IV bolus injection, single dosage
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Regadenoson n=100 Participants RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. Regadenoson: 400ug IV bolus injection, single dosage
Age, Categorical <=18 years	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=100 Participants
Age, Categorical >=65 years	35 Participants n=100 Participants
Age, Continuous	62 years n=100 Participants
Sex: Female, Male Female	40 Participants n=100 Participants
Sex: Female, Male Male	60 Participants n=100 Participants
Region of Enrollment United States	100 participants n=100 Participants

PRIMARY outcome

Timeframe: 1 hour observation post perfusion

Population: 60 Males, 40 Females being evaluated for coronary artery disease.

Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.

Outcome measures

Measure	Wall Motion n=100 Participants RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion. Wall motion was assessed by scoring as follows: 1=normal, 2=hypokinetic, 3=akinetic, and 4=dyskinetic. An inducible wall motion abnormality was one in which a new wall motion abnormality was evident after regadenoson bolus within at least 2 contiguous segments. A fixed defect was one in which the abnormality,was present at rest and did not change after the regadenoson bolus.	Myocardial Perfusion n=100 Participants RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine myocardial perfusion. Myocardial perfusion was assessed by examination of myocardial contrast replenishment after brief high mechanical index impulses. A perfusion defect was defined as a delay (\>2 seconds) in myocardial contrast replenishment in 2 contiguous segments.
Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress	98 Participants	98 Participants

Adverse Events

Arm One

Serious events: 0 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm One n=100 participants at risk RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. Regadenoson: 400ug IV bolus injection, single dosage Non-serious adverse effects during Regadenoson and Definity administration included chest pain in 7% of patients, shortness of breath in 48%, headache in 23% and back pain in 4%.
Cardiac disorders Chest Pain	7.0% 7/100 • Number of events 7 • 1 hour observation Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath \& back pain. Headaches were reported within 1 hour.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	48.0% 48/100 • Number of events 48 • 1 hour observation Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath \& back pain. Headaches were reported within 1 hour.
Vascular disorders Headache	23.0% 23/100 • Number of events 23 • 1 hour observation Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath \& back pain. Headaches were reported within 1 hour.
Musculoskeletal and connective tissue disorders Back pain	4.0% 4/100 • Number of events 4 • 1 hour observation Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath \& back pain. Headaches were reported within 1 hour.

Additional Information

Thomas Porter

University of Nebraska Medical Center

Phone: 402-559-5151

Email: trporter@unmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place