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Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of Ventricular Tachycardia
Patients with Ventricular Tachycardia (VT) who have failed standard therapy (medicines, invasive catheter ablation) have limited options, with one-year survival below 20%. Preclinical data demonstrate that single fraction stereotactic body radiotherapy (SBRT) to discrete portions of the heart is feasible and may result in a reduction or elimination of VT. The efficacy may be further improved when guided by cardiac electrophysiologic (EP) testing. In total, the mapping and ablation proposed for this EP-guided Noninvasive Cardiac Radioablation (ENCORE) is a rapid and totally non-invasive method. Overall safety and early efficacy of ENCORE have not been rigorously studied in a prospective trial to-date. The purpose of this phase I/II study is to demonstrate the short-term safety and preliminary efficacy of ENCORE for patients with life-threatening, treatment-refractory VT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stereotactic body radiotherapy (SBRT) | Experimental | Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiotherapy (SBRT) | Radiation | (Cardiac ablative radiotherapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures. | < or = 90 days |
| Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden | Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors. | 12 months (6mo prior to and 6mo post SBRT) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE. | 12 months |
| Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment |
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Inclusion Criteria:
DOCUMENTED VT:
Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
- OR-
Monomorphic PVCs documented on a 12-lead ECG.
ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
-AND-
CATHETER ABLATION: Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).
MINIMUM VT BURDEN: Patient must have either:
Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.
Patient must be > 18 years old.
Patient must be able to understand and be willing to sign an IRB approved written informed consent document.
-
Exclusion Criteria:
Patient must not have past history of radiotherapy within the projected treatment field.
Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))
Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).
More than 3 distinct clinical VT morphologies observed (ECG or ICD interrogation or invasive EP study) OR more than 5 distinct induced VT morphologies during ECGI testing.
Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.
Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.
Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.
-
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Cuculich, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30586734 | Derived | Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261. |
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Open sharing at the time of publication of results
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Nineteen patients were consented, screened, and deemed eligible for SBRT.
Two additional patients signed consent and went through screening procedures; however, were later deemed ineligible to obtain SBRT.
Twenty-one patients were consented between July 11, 2016 and December 20, 2017. These patients were evaluated as either inpatient or outpatient. Once patients met initial enrollment criteria, screening procedures were conducted to determine if the patient was eligible for SBRT.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Overall Who Received SBRT | Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2018 |
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Noninvasive Cardiac Radioablation, all subjects
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Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.
| 90 days to 12 months |
| Health Related Quality of Life (HRQOL) | The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state. | 6 week, 6 month, 12 month |
| Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden | Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors. | 6 months |
| Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden | Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors. | 6 months |
| Number of Participants With Reduction in ICD Shocks and LVEF Improvement | Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden. | 6 months |
| Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months | Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase. | 12 months |
| Primary Safety Endpoint (</=90 Days) | Phase 1 - Defined by a \ |
|
| Primary Efficacy Endpoint (6 Months) | Phase 2 - Number of subjects with a reduction in ICD therapies 6mo before and 6mo post-SBRT. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Overall Who Received SBRT | Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| BMI | Median | Full Range | kg/m^2 |
| |||||||||||||||||
| Age-Adjusted Charlson Comorbidity Index | The Charlson Comorbidity Index predicts 10-year survival in patients with multiple comorbidities. The Charlson Comorbidity Index scale ranges from 0 (no comorbidities) to 37 (all comorbidities in equation). The score is then adjusted based on the age of the patient, adding 0 to 4 points to the Charlson Comorbidity Index score, thus providing the Age-Adjusted Charlson Comorbidity Index. | Median | Full Range | Score |
| ||||||||||||||||
| Type of Cardiomyopathy | Count of Participants | Participants |
| ||||||||||||||||||
| Type of Nonischemic Cardiomyopathy | Based on the number of patients enrolled with nonischemic cardiomyopathy (8/19). | Count of Participants | Participants |
| |||||||||||||||||
| New York Heart Association (NYHA) Class | NYHA Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea; NYHA Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea; NYHA Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea; NYHA Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Count of Participants | Participants |
| |||||||||||||||||
| Left Ventricular Ejection Fraction | Median | Full Range | Percentage of Ejection Fraction |
| |||||||||||||||||
| Number of Previous Catheter Ablations | Median | Full Range | Invasive Procedures |
| |||||||||||||||||
| Total Number of Prior Catheter Ablation Approaches | Number | Invasive Ablation Approaches |
| ||||||||||||||||||
| Study Eligibility Criteria | Count of Participants | Participants |
| ||||||||||||||||||
| Device | Count of Participants | Participants |
| ||||||||||||||||||
| Current Antiarrhythmic Drugs | Number | Count of Participants |
| ||||||||||||||||||
| Other Medications | Number | Count of Participants |
| ||||||||||||||||||
| Variable | Number | Count of Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Serious Adverse Events | Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures. | Analysis is based on number of SAE events that occurred in 19 participants within 90 days after SBRT. | Posted | Number | Events | < or = 90 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden | Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors. | Percent reduction of VT episodes or PVC burden 6 months post-SBRT compared to 6 months prior to SBRT. Patients who were alive at 6 months were evaluated comparing ICD treatments or PVC burden 6 months before and 6 months post-SBRT. | Posted | Count of Participants | Participants | 12 months (6mo prior to and 6mo post SBRT) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment | Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria. | Analysis is based on number of AE events that occurred in 18 participants >90 days to 365 days post-SBRT. | Posted | Number | Number of Events | 90 days to 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (HRQOL) | The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state. | Posted | Mean | Full Range | Scores on a Scale | 6 week, 6 month, 12 month |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden | Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors. | One patient was excluded because they expired prior to the outcome measure time frame. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden | Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors. | One patient was excluded because they expired prior to the outcome measure time frame. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction in ICD Shocks and LVEF Improvement | Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden. | One patient was excluded because they expired prior to the outcome measure time frame. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months | Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase. | Posted | Count of Participants | Participants | 12 months |
|
|
Adverse Event data provided was obtained for all participants up to 1 year post-SBRT for last treated participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Overall Who Received SBRT | Noninvasive Stereotactic Body Radiotherapy (SBRT) will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging. Stereotactic Body Radiotherapy (SBRT): (Cardiac ablative radiotherapy) | 8 | 19 | 15 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastric Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intraoperative Cardiac Injury | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Multi-organ Failure | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Accident | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Chemical Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Amiodarone Induced |
|
| Other - Chest Pain NOS | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - ICD Lead Fracture | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Retroperitoneal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment | Due to MRI contrast |
|
| Ankle Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mitral Valve Disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Progression of existing mitral regurgitation |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Chest Pain NOS | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Congestive Gastropathy | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Dark Stools | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Gastroenteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Influenza | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Nephrolithiasis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Polydipsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Radiation Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other - Tendon Rupture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Retroperitoneal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Spacticity | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Testicular Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremors | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Amiodarone Induced |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phillip Cuculich | Washington University | 314-454-7698 | pcuculic@wustl.edu |
| Apr 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D009202 | Cardiomyopathies |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Myocarditis (Chronic) |
|
| Valvular |
|
| NYHA II |
|
| NYHA III |
|
| NYHA IV |
|
|
|
|
| ICD Therapies (>3 shocks or ATP in 6 months) |
|
| PVC-Related Cardiomyopathy |
|
|
| No Device |
|
|
|
| Low-Dose Amiodarone (<300mg per day) |
|
|
| Class III (excluding amiodarone) |
|
|
| Class I |
|
|
|
|
| Angiotensin Receptor Blocker |
|
|
| Oral Anticoagulation |
|
|
|
|
| Hypertension |
|
|
| Chronic Kidney Disease (Stage >/=3) |
|
|
| Title | Measurements |
|---|---|
|
| Grade 5 SAE (not treatment-related) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
12 month mean scores for all 13 evaluable patients at the 12 month time point. 5 patients had expired prior to the 12 month time point.
|
|
|
|
|
|