Trial Outcomes & Findings for Regadenoson Real Time Perfusion Imaging Trial-Optison (NCT NCT01489176)

Last Updated: 2024-10-08

Results Overview

Measurements will be analyzed to identify a coronary stenosis \>50% in diameter by quantitative cardiac angiography.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2024-10-08

Participant milestones
Measure	Regadenoson; Optison Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Regadenoson Real Time Perfusion Imaging Trial-Optison

Baseline characteristics by cohort
Measure	Regadenoson; Optison n=50 Participants Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
BMI	32 kg/m2 n=5 Participants
Percutaneous coronary intervention (PCI) Coronary artery bypass surgery (CABG)	17 Participants n=5 Participants
Hypertension	40 participants n=5 Participants
Hyperlipidemia	47 participants n=5 Participants
Diabetes	17 Participants n=5 Participants
Resting ejection fraciton (%)	57 percent n=5 Participants
Resting heart rate, bpm	67 beats per minute n=5 Participants
Peak heart rate, bpm	84 beats per minute n=5 Participants
Resting SBP, mm Hg	130 mm Hg n=5 Participants
Peak SBP, mm Hg	124 mm Hg n=5 Participants
Resting DBP, mm Hg	73 mm Hg n=5 Participants
Peak Diastolic Blood Pressure (DBP)	67 mm Hg n=5 Participants
Resting Rate Pressure Product (RPP)	8754 beats/minute*mmHg STANDARD_DEVIATION 1846 • n=5 Participants
Peak Rate Pressure Product (RPP)	11,738 beats/minute*mmHg STANDARD_DEVIATION 2,862 • n=5 Participants

Timeframe: 1 year

Measurements will be analyzed to identify a coronary stenosis \>50% in diameter by quantitative cardiac angiography.

Outcome measures
Measure	Regadenoson; Optison n=50 Participants Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Number of Participants With Coronary Stenosis	50 Participants

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Regadenoson; Optison n=50 participants at risk Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Cardiac disorders Chest Pain	14.0% 7/50 • Number of events 7
Respiratory, thoracic and mediastinal disorders Shortness of Breath	52.0% 26/50 • Number of events 26
General disorders Headaches	36.0% 18/50 • Number of events 18

University of Nebraska Medical Center

Phone: 402-559-5156