NEWS HIGHLIGHTS
Published Studies Related to Lexiscan (Regadenoson)
Attenuation of the side effect profile of regadenoson: a randomized double-blind
placebo-controlled study with aminophylline in patients undergoing myocardial
perfusion imaging and have severe chronic kidney disease--the ASSUAGE-CKD trial. [2013] A subgroup analysis of the ASSUAGE trial suggested that the standardized
intravenous aminophylline administration following regadenoson-stress leads to
substantial attenuation of regadenoson adverse-effects in patients with severe
chronic kidney disease (CKD)... In conclusion, the routine standardized
administration of intravenous aminophylline in patients with severe CKD
substantially reduces the frequency and severity of the adverse-effects
associated with regadenoson-stress without changing the ischemic burden.
A randomized, double-blind, placebo-controlled study assessing the safety and
tolerability of regadenoson in subjects with asthma or chronic obstructive
pulmonary disease. [2012] obstructive pulmonary disease (COPD)... CONCLUSIONS: This information may be helpful to physicians selecting a
Attenuation of the side effect profile of regadenoson: a randomized
double-blinded placebo-controlled study with aminophylline in patients undergoing
myocardial perfusion imaging. "The ASSUAGE trial". [2012] other adverse effects associated with regadenoson... CONCLUSIONS: This trial supports the routine administration of IV-aminophylline
Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study. [2011.02] BACKGROUND: Caffeine attenuates the coronary hyperemic response to adenosine by competitive A(A) receptor blockade. This study aims to determine whether oral caffeine administration compromises diagnostic accuracy in patients undergoing vasodilator stress myocardial perfusion imaging (MPI) with regadenoson, a selective adenosine A(2A) agonist... CONCLUSION: The results of this study will show whether the consumption of caffeine equivalent to 2-4 cups of coffee prior to an MPI study with regadenoson affects the diagnostic validity of stress testing (ClinicalTrials.gov number, NCT00826280).
Differences in heart rate response to adenosine and regadenoson in patients with and without diabetes mellitus. [2009.04] BACKGROUND: Adenosine and regadenoson increase heart rate (HR) when used as stress agents to produce coronary hyperemia due to direct sympathetic stimulation. We hypothesized that the HR response will be lower in patients with than in those without diabetes mellitus (DM)... CONCLUSIONS: The HR response to adenosine and regadenoson in patients with DM is blunted. If additional studies confer an agreement between traditional tests for determination of autonomic neuropathy and this measure, then examination of HR response to these agents during myocardial perfusion imaging might add prognostic power.
Clinical Trials Related to Lexiscan (Regadenoson)
Regadenoson to Achieve Maximal Hyperemia for Fractional Flow Reserve in the Catheterization Lab [Recruiting]
The purpose of this study is to determine if regadenoson is as safe and effective as
adenosine when used in the cardiac catheterization lab during measurement of coronary flow
reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional
Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when
hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising
patient safety.
Regadenoson and Adenosine [Completed]
The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady
state hyperemia as compared to central venous infusion of adenosine for assessing fractional
flow reserve. (adenosine is considered to be the gold standard)and to investigate the time
intervals of maximum hyperemia induced by centrally and peripherally administered
Regadenoson.
Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) [Completed]
Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type
1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors
have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes
(RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1
Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age
20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is
being followed for progression of coronary artery calcification (CAC) measured using the
electron beam tomography (EBT) for development of clinical CVD. Participants have been well
characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations
3 and 6 years later. The study has provided important insights into the risk factors and
possible prevention of premature CVD in T1D. We are proposing assess a subset of this
population to determine vasodilatory reserve as it relates to early coronary atherosclerosis
in T1D.
Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 DM using
regadenoson stress cardiac magnetic resonance and that significantly reduced MBF is a marker
of extensive atherosclerotic disease correlated to coronary arterial calcification, plaque
formation and impaired vasodilatory reserve.
Specific Aims:
1. Determine the relationship between myocardial perfusion index (previously determined),
regional CBF and invasively measured coronary flow reserve
2. Measure coronary blood flow using regadenoson stress CMR and determine the myocardial
blood flow reserve in type 1 DM subjects compared to non-diabetic controls.
3. Determine the relationship between CBF reserve in vascular distributions to the degree
of coronary arterial calcification.
4. Determine the severity of CBF blood flow reduction and the relationship to perfusion
reserve measured by invasive coronary Doppler flow-wire under regadenoson between in
type 1 DM subjects compared to non-diabetic controls.
A Phase II Trial of Regadenoson in Sickle Cell Anemia [Recruiting]
This research study is a Phase II clinical trial, which tests the safety and effectiveness
of an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works
in treating a specific disease, in this case Sickle Cell Disease (SCD). "Investigational"
means that the drug is being studied. It also means that the FDA has not yet approved the
drug for your type of disease.
SCD is an inherited blood disorder that causes the red blood cells to change their shape
from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a
different type of protein that carries oxygen in their blood (hemoglobin) than people
without SCD. This different type of hemoglobin makes the red blood cells change into
crescent shape under certain conditions. Sickle-shaped cells are a problem because they
often get stuck in the blood vessels blocking the flow of blood, and cause inflammation and
injury to important areas in the body.
Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury
caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast
infusion during a heart stress test in people who are unable to exercise enough to put
stress on their heart by making the heart beat faster. Regadenoson has been studied as a
long infusion at this dose in adults, and no safety issues have been identified
(ClinicalTrials. gov Identifier: NCT01085201). This is the first study to look at patient
benefit with the long infusion of the drug. This drug has been used in laboratory
experiments and information from those other research studies suggests that this drug may
help to protect the body from damage caused by sickle-shaped cells in this research study.
In this research study, the investigators are specifically looking to see if Regadenoson is
an effective treatment for pain crises and acute chest syndrome in SCD.
Regadenoson Real Time Perfusion Imaging Trial-Optison [Recruiting]
The purpose if this study is to examine how effective Regadenoson is in detecting coronary
artery disease during a stress echocardiogram when Optison is administered. Optison is a
contrast agent that improves the images of the heart on the echocardiogram (echo) machine.
Optison is approved by the Food and Drug Administration (FDA) to use during stress
echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is
used to chemically increase the heart rate and is approved for nuclear imaging tests.
Regadenoson is a FDA approved drug but not for the intended use in this study.
Reports of Suspected Lexiscan (Regadenoson) Side Effects
Unresponsive TO Stimuli (16),
Dyspnoea (14),
Chest Pain (12),
Cardiac Arrest (11),
Hypotension (10),
Respiratory Arrest (9),
Bradycardia (9),
Loss of Consciousness (7),
Death (7),
Acute Myocardial Infarction (7), more >>
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