Cardiac Imaging Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following cardiac imaging clinical trials:
• Nuclear Cardiology Database: Patient Outcome Studies
• Early Identification of Sub clinical Atherosclerosis Using Noninvasive Imaging Research (Eisner): Study 4: Cardiac CT Database
• CSMC Cardiovascular Magnetic Resonance Imaging Database
• A Phase 2, Open-Label, Randomized Multi-center Study for the Development of One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158
• Coronary Anatomy and Physiology Using "Single Shot" Multi-detector Dual Source Computed Tomography with Adenosine Enhancement: Comparative Study with SPECT Imaging: Pilot Studies I and II
• Integrated Multi-Modality Imaging and Electrical Substrate Evaluation to Predict Sustained Success of Radiofrequency Ablation in Non-valvular Atrial Fibrillation: Pilot Study for the IMAGE-AF Initiative
• Combined Fluorodeoxyglucose Positron-Emission Tomography and Coronary Computed Tomography Angiographic Imaging of Coronary Plaque After Percutaneous Coronary Intervention for Acute Coronary Syndrome and Stable Coronary Disease
• Prospective, Multi-Center Registry Study for Clinical Outcome in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) Examination - Visipaque Registry Study – Protocol GE-012-096
• Ultra Low Dose Coronary Artery Calcium Screening Using Dual Source CT Prospective ECG Gating
• Fatty Diet to Reduce Myocardial Uptake During Fluorine-18-Labeled Deoxyglucose Positron-Emission Tomography
• Coronary Computed Tomography for Systemic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
• SPARC: Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in Coronary Artery Disease (CAD)
• Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research (Eisner) Study 1: CSMC Community
• Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research (Eisner) Study 2R: Patients with Myocardial Perfusion SPECT
• A Comparison between High Speed D-SPECT® and Dual Detector Anger Camera (A-SPECT) Myocardial Nuclear Imaging for Detection of CAD
• Localization of Coronary Plaque by Combining Fluorodeoxyglucose Positron-Emission Tomography and Computed Tomographic Coronary Angiography
• Combined Fluorodeoxyglucose Positron-Emission Tomography and Coronary Computed Tomography Angiographic Imaging of Coronary Plaque in Acute Myocardial Infarction
• An Open-Label, Multicenter, Phase III Study Evaluating the Prognostic Usefulness of ¹²³I-mIBG Scintigraphy for Identifying Subjects with Heart Failure who will Experience An Adverse Cardiac Event
• An Open Label, Multicenter, Phase 3 Study to Demonstrate the Prognostic Usefulness of ¹²³I-MIBG Imaging for Identifying Subjects with Heart Failure who will Experience an Adverse Cardiac Event during 24 Months Follow-up
• Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research (Eisner): Study 5: Genetic Blood Bank
• The Glazer Grant: Multimodality imaging of the coronary artery disease patient: improved risk assessment and assessment of therapy.
• Automatic Quantitative CT Imaging of Pericardial Fat: A Novel Ischemia Predictor (NIH)
• Automated Quantitative Plaque Characterization with Coronary CT Angiography (AHA)
• High-Performance Automated System for Analysis of Cardiac SPECT (NIH)
Nuclear Cardiology Database: Patient Outcome Studies
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 1752
Contact: Nancy Zambrana (310) 423-3763
Status: Enrolling
Summary: This long term study is the world’s largest database (4500-5000 subjects enrolled annually) of historical, demographic, clinical and outcome data of patients who have undergone nuclear cardiology studies. Information collected from patients coming to Cedars-Sinai Medical Center for clinically ordered SPECT tests is used to perform various research analyses such as investigating how myocardial perfusion SPECT imaging predicts future outcomes (e.g. cardiac death, heart attacks, or heart surgery). The objectives and goals of the research performed under this program will expand as new information is obtained and/or as new imaging techniques and analytical tools are developed. Under this protocol, patients may be contacted several times over a ten-year period to collect outcome data.
Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research
(Eisner): Study 4: Cardiac CT Database
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 3354
Contact: Nancy Zambrana (310) 423-3763
Status: Enrolling
Summary: With over 16,000 subjects enrolled in this non-invasive outcomes database, the information collected will allow researchers to investigate the predictive value of coronary calcium for clinical outcomes in the early detection and management of coronary artery disease. In 2006, investigators added CT Angiography to the data to be collected. This newer technology expands the role that non-invasive CT imaging will play in the diagnosis of CAD.
CSMC Cardiovascular Magnetic Resonance Imaging Database
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 4317
Contact: Nancy Zambrana (310) 423-3763
Status: Enrolling
Summary: This observational study aims to use collected baseline clinical and image data and follow up outcome data to investigate the utility of clinical cardiac MR imaging for diagnosis and management across the spectrum of cardiovascular disease in patients referred to cardiac MRI.
As with the other imaging databases, this project includes a wide representation of patients allowing researchers to investigate numerous subgroups to help physicians diagnose various cardiovascular illnesses and guide their treatment decisions for their patients.
A Phase 2, Open-Label, Randomized Multi-center Study for the Development of One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 17284
Contact: Nancy Zambrana (310) 423-3763
Status: Enrolling
Summary: The BMS747158-201 study is designed to acquire the data necessary to develop one-day rest/stress PET perfusion imaging protocols for BMS747158 with image quality comparable to a two-day rest/stress protocol. While human dosimetry studies have demonstrated the radiation safety of clinically useful doses of BMS747158, this Phase 2, multi-center study will determine optimal dosing and imaging capabilities for a clinically practical protocol. To date, Cohort 1 of this study is complete, with subjects in Cohort 2 using doses, dosing time intervals, and imaging parameters determined in Cohort 1. Subjects will have a cardiac PET scan using the study drug and a cardiac SPECT scan, the results of which will serve as the comparator for the primary and secondary endpoints in this study. As part of the protocol, investigators will use a specified timeline to follow up on adverse cardiac events.
Coronary Anatomy and Physiology Using "Single Shot" Multi-detector Dual Source Computed Tomography with Adenosine Enhancement: Comparative Study with SPECT Imaging:
Pilot Studies I and II
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 10928 / 11143
Contact: David Choi (310) 423-0075
Status: Enrolling
Summary: CT technology is evolving at a fast rate as investigators search for new ways to gather functional and anatomical information with improved resolution, lessening of motion artifacts and ease of performance. Researchers hope that the DSCT, non-invasive scanner, will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam. These investigator-initiated trials will validate and compare Adenosine-Dual Source CT perfusion imaging (DSCT) with Adenosine-SPECT obtained in the same patient during the same period of stress testing (Pilot I) / and where patients have had an initial positive SPECT finding (Pilot 2). To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease.
Integrated Multi-Modality Imaging and Electrical Substrate Evaluation to Predict Sustained Success of Radiofrequency Ablation in Nonvalvular Atrial Fibrillation: Pilot Study for the IMAGE-AF Initiative
Principal Investigator: Victor Cheng, MD
IRB Approval Number: 19554
Contact: Victor Cheng, MD (310) 248-7964
Status: Enrolling
Summary: The purpose of this pilot study is aimed at improving our current ability to predict whether a patient with atrial fibrillation will receive sustained benefit from a procedure called "ablation". Investigators will evaluate whether integrating data from imaging (cardiac CTA) and electrical mapping of the left atrium will improve prediction of patients likely to fail ablation, when compared to imaging alone or electrical mapping alone.
Combined Fluorodeoxyglucose Positron-Emission Tomography and Coronary Computed Tomography Angiographic Imaging of Coronary Plaque After Percutaneous Coronary Intervention for Acute Coronary Syndrome and Stable Coronary Disease
Principal Investigator: Victor Cheng, MD
IRB Approval Number: 16182
Contact: Nancy Zambrana (310) 423-3763
Status: Enrollment closed
Summary: To qualify for this study, a patient must have been diagnosed with acute or chronic coronary disease and just successfully underwent angioplasty and/or stent placement. After angioplasty, the patient will undergo specialized research heart PET and heart CT scans. Investigators will try to determine whether the combination of FDG-PET and 64-slice CCTA can discern expected differences in plaque inflammation between those causing acute coronary syndrome and stable coronary disease. Experts in heart imaging and computer software within the team of investigators will help merge images from the heart PET and heart CT scans to create a “hybrid scan”. Specially-trained cardiologists within the team of study investigators will evaluate the “hybrid scan” to determine the location of each inflamed coronary plaque. This information will be compared to results from the invasive coronary angiogram.
Prospective, Multi-Center Registry Study for Clinical Outcome in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) Examination - Visipaque Registry Study –
Protocol GE-012-096
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 16977
Contact: Johanna Kim (310) 423-0796
Status: Enrollment closed
Summary: This is a phase 4, prospective, multi-center study in symptomatic subjects undergoing clinical VISIPAQUE-enhanced Coronary CTA. The study will collect information at baseline, and at 1, 6, and 12-month time-points after the clinical CCTA procedure. Investigators are looking to gather information from outcomes data as well as to assess prognostic value in terms of sensitivity, specificity, positive predictive value and negative predictive value of CCTA examination when compared to a standard of truth, i.e., subject’s subsequent coronary artery angiography findings or binary subject outcomes during each follow-up period
Ultra Low Dose Coronary Artery Calcium Screening Using Dual Source CT Prospective ECG Gating
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 14860
Contact: Johanna Kim (310) 423-0796
Status: Enrolling
Summary: This is a project to compare the current standard imaging protocol for coronary calcium screening (CCS) using Dual source CT to a new imaging technique using lower radiation. In summary, results show that low-dose coronary calcium scoring gives equivalent results to the standard method, at a significantly lower radiation dose. A manuscript is now in preparation and further studies are being planned.
Fatty Diet to Reduce Myocardial Uptake During Fluorine-18-Labeled Deoxyglucose Positron-Emission Tomography
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 11213
Contact: Nancy Zambrana (310) 423-3763
Status: Enrollment Closed
Summary: Physiologic myocardial uptake of radionuclide-labeled fluorodeoxyglucose (18FDG) is a common phenomenon that complicates evaluation of thoracic images on 18FDG-PET. With mounting interest in the use of 18FDG-PET to identify coronary arterial inflammation, the problem posed by unwanted myocardial uptake will be further magnified. This is a prospective, randomized, single-blinded study to measure the effect of a high-fat/low-carbohydrate diet in suppressing myocardial 18FDG uptake. Results from this study will be compared to unrestricted and low-carbohydrate diets in determining the effect of diet in reducing heart artifact on 18FDG-PET images.
Coronary Computed Tomography for Systemic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 11662
Contact: Nancy Zambrana (310) 423-3763
Status: Follow-up
Summary: This prospective, randomized, multicenter study is designed to evaluate a new approach in the diagnosis of acute chest pain patients entering the emergency department (ED). This study will compare the safety, diagnostic efficacy and efficiency of multi-slice computed tomography (MSCT) to the standard of care treatment of low to intermediate risk acute chest pain patients in the Emergency Department. MSCT has been shown to have high accuracy in the ability to correctly diagnose the cause of this type of chest pain. In addition, because MSCT is a much faster test when compared with the standard of care testing, this approach could contribute to greater efficiency of diagnosis and the associated lower cost for the patient.
SPARC: Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in Coronary Artery Disease (CAD)
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 9584
Contact: Nancy Zambrana (310) 423-3763
Status: Follow-up
Summary: Bracco, Astellas and GE Healthcare are funding a large (n=4000) prospective, open-label, multi-center observational study to determine the medical value of several new non-invasive cardiac imaging tests. The primary objectives of the main study are to assess the impact of Myocardial Perfusion (stress SPECT and stress PET), CT Coronary Angiography and combined Myocardial Perfusion-CTA imaging (PET/CT) on post-test resource utilization as measured by referral to early catheterization and to determine the incremental prognostic value of these tests for predicting cardiac death and nonfatal myocardial infarction.
Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research (Eisner) Study 1: CSMC Community
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 3351
Contact: Johanna Moon (310) 423-0796
Status: Follow-up
Summary: The EISNER study is a multi-project study to assess the various aspects of coronary artery disease. The primary purpose of Study 1 is to determine if a particular combination of assessments (medical history and risk factor information, clinical and biochemical tests, and a cardiac CT scan) can predict future clinical outcomes (e.g. progression of atherosclerosis, heart surgery) in patients who have had no symptoms of coronary artery disease or other heart disease. Over 2100 asymptomatic patients were randomized to either have a cardiac CT scan for coronary calcification or not in a 2:1 ratio. Data was collected on all subjects over a four-year follow-up period.
Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research (Eisner) Study 2R: Patients with Myocardial Perfusion SPECT
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 3974
Contact: Johanna Moon (310) 423-0796
Status: Follow-up
Summary: The objective of EISNER 2R is to assess the added value of cardiac CT scanning and coronary calcium over information derived from clinical, biochemical, and stress myocardial perfusion SPECT (MPS) variables in detecting subclinical CAD. Although cardiac CT scanning has been shown to be useful in detecting subclinical coronary artery disease (CAD), the relative usefulness of cardiac CT findings, clinical, and biochemical assessments in predicting outcomes in CAD when combined with nuclear cardiology findings has not been explored.
A Comparison between High Speed D-SPECT® and Dual Detector Anger Camera (A-SPECT) Myocardial Nuclear Imaging for Detection of CAD
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 9375
Contact: Nancy Zambrana (310) 423-3763
Status: Study Closed
Summary: This was a prospective single clinical trial to compare the ability of A-SPECT (dual detector Anger Camera SPECT) and D-SPECT® (Spectrum Dynamics SPECT) to detect myocardial perfusion abnormalities during stress myocardial perfusion SPECT. Compared to the standard Anger scintillation cameras used in cardiac imaging, D-SPECT® technology incorporates a new design that reduces the time needed to acquire cardiac SPECT images and allows for the patient to be more comfortably positioned.
Localization of Coronary Plaque by Combining Fluorodeoxyglucose Positron-Emission Tomography and Computed Tomographic Coronary Angiography
Principal Investigator: Victor Cheng, MD
IRB Approval Number: 11099
Contact: Nancy Zambrana (310) 423-3763
Status: Study Closed
Summary: This pilot study was to determine whether abnormal cardiac region uptake seen on fluorine-18-labeled deoxyglucose PET (18FDG-PET) correlates anatomically to coronary artery plaque, detected by 64-slice CT coronary angiography.
Combined Fluorodeoxyglucose Positron-Emission Tomography and Coronary Computed Tomography Angiographic Imaging of Coronary Plaque in Acute Myocardial Infarction
Principal Investigator: Victor Cheng, MD
IRB Approval Number: 14827
Contact: Nancy Zambrana (310) 423-3763
Status: Study Closed
Summary: This study was designed to determine whether the combination of fluorine-18-labeled deoxyglucose positron-emission tomography and 64-slice coronary computed tomographic angiography can identify plaque(s) responsible for acute myocardial infarction
An Open-Label, Multicenter, Phase III Study Evaluating the Prognostic Usefulness of ¹²³I-mIBG Scintigraphy for Identifying Subjects with Heart Failure who will Experience An Adverse Cardiac Event
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 7088
Contact: Johanna Kim (310) 423-0796
Status: Study Closed
Summary: ¹²³I-mIBG is a medication containing radioactive iodine currently approved in Europe to take pictures of the heart. It is being studied to see if having abnormal heart function (HF) increases an individual's risk of a future adverse cardiac event. Among the factors that affect this risk are the nerves that control the heart’s rhythm and its ability to pump effectively. Because ¹²³I-mIBG uptake reflects the nerve path and amount of stimulation to the heart, ¹²³I-mIBG images may allow us to better identify subjects who will experience an adverse event, thereby reducing the incidence and helping us to better understand the causes of sudden cardiac death. GE Healthcare is the study sponsor and manufacturer of ¹²³I-mIBG.
An Open Label, Multicentre, Phase 3 Study to Demonstrate the Prognostic Usefulness of ¹²³I-MIBG Imaging for Identifying Subjects with Heart Failure who will Experience an Adverse Cardiac Event during 24 Months Follow-up
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 15486
Contact: Johanna Moon (310) 423-0796
Status: Study Closed
Summary: Cedars-Sinai Medical Center was an approved clinical site in IRB #7088 (Protocol MBG312) for which enrollment is complete. This new extension trial (Protocol MBG313) is a phase 3, open-label, multicentre trial to investigate the prognostic usefulness of 123I-mIBG imaging to identify those subjects with NYHA Class II or III HF who will experience an Adverse Cardiac Event during 24 months follow-up. This was an extension of the initial protocol to accomplish additional data collection.
Early Identification of Subclinical Atherosclerosis Using Noninvasive Imaging Research
(Eisner): Study 5: Genetic Blood Bank
Principal Investigator: Daniel Berman, MD
IRB Approval Number: 3355
Contact: Johanna Kim (310) 423-0796
Status: Follow-up / Analysis only
Summary: Coronary artery disease (CAD) is a multi-factoral and multi-stage disease which no single test ever predicts well. Recent medical literature today suggests a variety of new genetic markers that may serve as predictors of cardiac events including the presence or development of early atherosclerosis. The purpose of developing this bank is to have specimens available for the investigation of such genetic markers. The advantage that this bank will also offer is the ability to link the results of the genetic analyses to the clinical data, historical data, coronary calcium measurements, biochemical results and other assessments measured during the EISNER studies.
The Glazer Grant: Multimodality imaging of the coronary artery disease patient: improved risk assessment and assessment of therapy.
Principal Investigator: Damini Dey, PhD
IRB Approval Number: 6318
Contact: Damini Dey (310) 423-1517
Status: Data Analysis only
Summary: The general objectives of this grant are to improve noninvasive imaging methods for patient risk assessment and evaluation of serial changes in CAD, by developing advanced software algorithms for analyzing CT, SPECT and PET images.
Automatic Quantitative CT Imaging of Pericardial Fat: A Novel Ischemia Predictor (NIH)
Principal Investigator: Damini Dey, PhD
IRB Approval Number: 13964
Contact: Damini Dey (310) 423-1517
Status: Data Analysis only
Summary: The major goal of this project is to develop fully automated, accurate, new computer software for quantitation of pericardial fat from cardiac CT images acquired for routine assessment of coronary calcium to better identify patients who are “vulnerable” to sudden myocardial infarction. Data used for project: is from EISNER studies 1, 2, and 4 (IRB # 3351, 3974, 3354)
Automated Quantitative Plaque Characterization with Coronary CT Angiography (AHA)
Principal Investigator: Damini Dey, PhD
IRB Approval Number: 19424
Contact: Damini Dey (310) 423-1517
Status: Data Analysis only
Summary: The PI and co-investigators at CSMC have developed a preliminary fully automatic volumetric analysis capable of accurate, rapid quantitation and characterization of atherosclerotic plaque lesions from standard CCTA and propose to refine, validate and evaluate the prognostic value of this approach. This goal will be accomplished through two specific aims: 1) validation of the developed methods by comparison to expert human observers and invasive “gold standard” modalities; and 2) assessment of the prognostic value in prediction of cardiac death.
High-Performance Automated System for Analysis of Cardiac SPECT (NIH)
Principal Investigator: Piotr Slomka, PhD
IRB Approval Number: 19604
Contact: Piotr Slomka (310) 423-4348
Status: Data Analysis only
Summary: This NIH grant aims to develop a fully automated computer analysis system for Myocardial Perfusion SPECT (MPS). This research will develop techniques for improved automation of left ventricular contour detection, motion and perfusion quantification, and quantification of attenuation corrected MPS. The newly developed quantification methods will be integrated into an automated clinical tool that researchers hypothesize will be able to detect Coronary Artery disease and predict outcomes such as cardiac death better than the best attainable visual analysis.
