Phase 2 N=20 Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI
Myocardial Ischemia
Primary: Quantification of Myocardial Blood Volume — 3.63; 1.23 seconds^-1
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N/A N=35 Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve
Coronary Artery Disease
Primary: Correlation in MBF Between Core Laboratory and Local Site — 0.93 correlation coefficient
N/A N=12 Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Coronary Artery Disease
Primary: Global Hyperemic Myocardial Blood Flow (MBF) — 3.1; 3.1 mL/min/gm — p=0.14
N/A N=32 Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)
Coronary Heart Disease
Primary: Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT — 0.06 mean residual difference in MBF
N/A N=21 PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Coronary Artery Disease
Primary: Number of Flow-limiting Coronary Artery Stenosis on CT — 8 Coronary arteries
Phase 4 N=26 Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)
Coronary Artery Disease · Type 1 Diabetes Mellitus
Primary: Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects. — 2.19; 1.81; 1.95 percentage of StressMBF/ Rest…
N/A N=15 Coronary Flow Reserve Following Orbital Atherectomy
Coronary Artery Disease
Primary: Coronary Flow Reserve (CFR) — 2.23 Ratio
Phase 2 N=232 Myocardial Perfusion MRI
Myocardial Perfusion Imaging · Magnetic Resonance Imaging
Primary: Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of…
N/A N=20 The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI
Coronary Artery Disease
Primary: Myocardial Blood Flow — 1.60; 0.96; 2.40 mL/g/min
N/A N=50 Coronary Flow Reserve to Assess Cardiovascular Inflammation (CIRT-CFR)
Coronary Heart Disease · Metabolic Syndrome · Diabetes Mellitus
Primary: Change in Global Myocardial Blood Flow in Response to Vasodilator — 0.05; -0.145 percentage change in CFR
Phase 4 N=80 Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation
Myocardial Blood Flow Reserve
Primary: Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson) — 2.57 Ratio
N/A N=120 Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging
Coronary Disease
Primary: Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT. — 78 % accurately detected…
N/A N=44 Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Coronary Artery Disease · CAD
Primary: Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images — 95; 94 percentage of true cases
Phase 4 N=16 Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Ischemic Heart Disease
Primary: Diagnostic Accuracy of Cardiac PET/MRI Examination — 50; 64; 61; 64 percentage — p=0.35
Phase 3 N=40 Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Heart Disease, Ischemic · Atherosclerosis, Coronary
Primary: Magnetic Resonance Image Quality Rating — 3.57; 2.55 units on a likert scale — p=<0.001
N/A N=30 Effects of Body Mass Index on the Hyperemic Response to Regadenoson
Obesity · Endothelial Dysfunction · Decreased Vascular Flow
Primary: Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest) — 2.25; 2.44 ratio…
N/A N=116 COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Aortic Stenosis · Coronary Artery Disease
Primary: FFR 6 Months After SAVR/TAVI. — -0.0279 ratio
Phase 4 N=20 Stress Testing and Cardiac Magnetic Resonance
Coronary Disease
Primary: Major Adverse Cardiovascular Events — 0 Participants
N/A N=18 A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Type 2 Diabetes Mellitus
Primary: Myocardial Fatty Acid Uptake Rate — 18.492; 2.123; 36.005; 7.8 umol/min/100g
N/A N=10 Measurement of Kidney Blood Flow and Oxygen Levels by MRI
Chronic Kidney Disease
Primary: Measurement of Renal Blood Flow of the Kidney by the PAH Method — 190 ml/min
N/A N=50 Myocardial Stress Perfusion Imaging With Dual Source CT
Coronary Artery Disease
Primary: Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. — 79 percentage of…
N/A N=329 Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan
Coronary Artery Disease
Primary: Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter…
Phase 1 N=46 Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
Coronary Artery Disease
Primary: Difference in FFR Between IV Adenosine and IV Regadenoson — 0.84; 0.84 ratio (Pd/Pa)
N/A N=242 Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
Multi Vessel Coronary Artery Disease · STEMI
Primary: Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD…
N/A N=40 Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing
Cardiac Function
Primary: Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic…
Phase 4 N=697 Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Ischemic Heart Disease
Primary: Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement — 140 participants
N/A N=276 HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography
Coronary Artery Disease
Primary: AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis — .90; .81 probablility
N/A N=1,500 A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Coronary Disease · Coronary Stenosis
Primary: MACCE — 80; 51 Participants — p=0.35
Phase 4 N=14 Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
Heart Transplant · Acute Graft Rejection · Chronic Graft Rejection
Primary: Myocardial Perfusion Reserve — 1.52; 1.94 arbitrary units
N/A N=285 Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
Coronary Artery Disease
Primary: Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone — 73; 64 percentage of participants