Phase 4 Completed N=80 Randomized Diagnostic

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

Myocardial Blood Flow Reserve

Source: ClinicalTrials.gov NCT01919450 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Mar 2017

Primary outcomePrimary: Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) — 2.57 Ratio

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)	2.57	—
PRIMARY Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)	2.93	—
PRIMARY Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)	2.34	—
PRIMARY Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)	2.76	—

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01919450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.