Trial Outcomes & Findings for Effects of Body Mass Index on the Hyperemic Response to Regadenoson (NCT NCT00859833)

Results Overview

The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

2 hours

Results posted on

2011-05-24

Participant Flow

Patients were recruited from medical clinics and by advertising within the hospital.

Participant milestones

Participant milestones
Measure	Adenosine Followed by Regadenoson Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Body Mass Index on the Hyperemic Response to Regadenoson

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenosine Followed by Regadenoson n=30 Participants Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
Region of Enrollment United States	30 participants n=5 Participants
Age Continuous	49.5 years STANDARD_DEVIATION 11.5 • n=5 Participants
Age, Customized Between 18 and 65 years	30 participants n=5 Participants
Age, Customized >=65 years	0 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.

The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)

Outcome measures

Outcome measures
Measure	Adenosine n=28 Participants Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).	Regadenoson n=28 Participants Regadenoson 0.5 mg i.v. bolus.
Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)	2.25 ratio Standard Deviation 0.59	2.44 ratio Standard Deviation 0.91

Adverse Events

Adenosine Followed by Regadenoson

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheldon Litwin

Univesity of Utah

Phone: 801-581-7715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60