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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=33 Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD
Congenital Heart Disease
Primary: Mean Difference in Stroke Volume Between CMR and SMIC — 1.7 ml — p=0.47
Phase 2 N=80 Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
Cardiac Catheterization · Blood Pressure · Heart Ventricles
Primary: Agreement Between SHAPE and Pressure Catheter Measurements — -0.8; -0.8 Correlation coefficient value
Phase 3 N=426 Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Coronary Artery Disease
Primary: Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based…
N/A N=63 Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Heart Failure
Primary: A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram — 19; 10 Participants
Phase 3 N=478 Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Coronary Artery Disease
Primary: Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded…
Phase 2 N=55 Cardiac Electrophysiological Study
Atrial Flutter
Primary: LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) — 11; 43; 55; 50 ms
N/A N=47 Focused Cardiac Ultrasound
Ventricular Dysfunction · Pericardial Effusion · Valvular Disease
Primary: Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. — 13; 13; 9; 4 Participants
N/A N=110 Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
Acute Coronary Syndrome · Chest Pain
Primary: Cost of Index Hospitalization — 2062; 2680 US Dollars
N/A N=105 Randomized Investigation of Chest Pain Diagnostic Strategies
Acute Coronary Syndrome · Chest Pain
Primary: The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. — 7; 20 participants
N/A N=10 On-pump Intraoperative Echocardiography
Septal Myectomy
Primary: Septal Thickness Measured Before Cardiopulmonary Bypass — 22.9; 22.5 millimeters
N/A N=3,000 Diagnostic Accuracy of Electrocardiogram for Acute Coronary Occlusion Resulting in Myocardial Infarction
Myocardial Infarction · Acute Coronary Syndrome · Coronary Artery Disease
Primary: The Sensitivity and Specificity of ECG for Acute Coronary Occlusion. — 767; 282; 16 Participants
N/A N=34 Vis-Rx Prime Micro-Imaging Catheter Study
Coronary Artery Disease
Primary: Technical Performance — 56.0 millimeters — p=0.0001
N/A N=27 Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study
Peripheral ICC
Primary: VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data — 20 subjects who digital data was captured
N/A N=11 Hemodynamics Measurement in Radiofrequency Catheter Ablation
Cardiac Arrhythmia
Primary: Systolic Pressure Value — 26.5; 27.75; 16.6; 13.6 millimeters of mercury (mmHg)
N/A N=983 Safety Assessment of Angioplasty Procedures
Angiospastic; Disorder
Primary: Number of Major Adverse Cardiac Events (MACE) — 9; 6; 2; 119 Participants
N/A N=1,509 Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
N/A N=101 Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
Chest Pain
Primary: Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model — 2.75; 2.95 score on a scale
N/A N=203 Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?
Coronary Artery Disease
Primary: Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) — 147…
N/A N=24 Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Atrial Fibrillation · Heart Failure
Primary: Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events — 5; 2; 2; 7 participants
N/A N=2,103 The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Coronary Artery Disease
Primary: Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease — 44; 118; 18; 12 number of events — p=<.001
N/A N=306 Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
Coronary Artery Disease
Primary: The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. — 73.4 percentage of 100
Phase 4 N=20 Stress Testing and Cardiac Magnetic Resonance
Coronary Disease
Primary: Major Adverse Cardiovascular Events — 0 Participants
Phase 4 N=134 Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking
Ischemia
Primary: Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia — 0.1538; 0.2308 proportion of participants
Phase 3 N=1,101 Evaluation of a New Cardiac Biomarker Assay
Acute Coronary Syndrome · Acute Myocardial Infarction
Primary: Clinical Performance - Area Under the Curve — 0.9326; 0.9197; 0.9412; 0.9431 Probability
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
N/A N=27 An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Cardiac Arrhythmia
Primary: Baseline Noise Comparison — 19; 46; 31; 463 μV
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 3 N=22 Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients
Orthotopic Heart Transplant
Primary: Coronary Flow Reserve (CFR) — 1.77 ratio: peak to baseline CFV