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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerance of a new intravenous diagnostic agent, SeeMore or EVP 1001-1, in patients with Cardiovascular Disease (MEMRI scan). The initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed. This second phase adds 10 patients in a safety cohort and 60 additional patients for a total of 70 patients.
This is an open-label, baseline-controlled study to be conducted. Adult male or nonpregnant female patients who have been referred for evaluation of dilated cardiomyopathy, ischemic cardiomyopathy, non-ischemic cardiomyopathy, atrial arrhythmia and also patients who have received stem cell therapy related to both ischemic and dilated cardiomyopathy (under different trials) will be recruited. An initial cohort study of 6 patients to conduct safety evaluation was conducted before proceeding with 60 additional patients. In the initial cohort, a patient was dosed based on the Phase 1 and 2 clinical trial data evaluation completed by Eagle Vision Pharmaceutical, Inc. Subjects were excluded if they had received an investigational device within 30 days prior to administration of EVP1001-1; had a history of drug abuse or alcoholism; were taking a digitalis preparation; had a history of torsades; had New York Heart Association (NYHA) Grade IV heart failure; had abnormal liver function tests or a history of liver disease; had uncontrolled hypertension; had abnormal calcium, potassium or hemoglobin values at baseline; if they develop a cardiac arrhythmia prior to or during either of the exercise tests-- EVP1001-1 was not administered. The same parameters will apply to the new group of subjects.
Prior to entry into this study, all subjects will sign an Informed Consent and will undergo a physical examination including medical history, details regarding their cardiac history, prescription and over-the-counter drug questionnaire, vital signs, electrocardiogram (ECG), evaluation of the major organ systems, hematology, serum chemistries, and urinalysis. In addition, female subjects will undergo a serum pregnancy test.
Starting 30 minutes before the cardiac MRI scan (CMR), the subjects will take a 16 mg tablet of ondansetron by mouth. CMR imaging will subsequently take place and then EVP1001-1 will then be administered approximately 15 minutes into the scan for contrast enhanced images. EVP1001-1 will be administered intravenously over approximately one minute. The subjects will each receive 0.28 mL/kg of EVP 1001-1. All subjects will be monitored closely from before ondansetron administration until their discharge from the imaging center. Following MEMRI, delayed-enhanced MRI (DEMRI scan) is performed using 0.2 mmol/kg.
We will compare the two different contrast enhanced images (EVP1001-1 vs gadolinium (GD)) in determining the non-viable (infarct core), peri-infarct, and total infarct size of myocardial tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Disease | Experimental | Participant receive 2 cardiac MRI procedures: MEMRI and DEMRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manganese-enhanced MRI contrast reagent | Drug | MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Size of MEMRI Versus DEMRI Scans | MEMRI is an assessment of non-viable myocardial tissue and evaluates core infarct size. DEMRI is an assessment of fibrotic tissue and evaluates the total infarct size. The difference between these two measurements evaluates the size of peri-infarct region consisting of mixed components of injured but viable cardiomyocytes and fibrosis. | Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg. | Before, during, and after MEMRI scan (up to 3 hours) |
| Diastolic Blood Pressure |
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Inclusion Criteria:
All subjects to be entered must:
Exclusion Criteria:
have a positive pregnancy test (females)
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| Name | Affiliation | Role |
|---|---|---|
| Phillip C Yang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary Disease Patients | Participants receive 2 cardiac MRI procedures: manganese-enhanced MRI (MEMRI; manganese 0.28 mL/kg as reagent); and delayed-enhanced MRI (DEMRI; gadolinium 0.2 mmol/kg as reagent). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who had both MEMRI and DEMRI scans were considered evaluable for baseline characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | Coronary Disease Patients | Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Infarct Size of MEMRI Versus DEMRI Scans | MEMRI is an assessment of non-viable myocardial tissue and evaluates core infarct size. DEMRI is an assessment of fibrotic tissue and evaluates the total infarct size. The difference between these two measurements evaluates the size of peri-infarct region consisting of mixed components of injured but viable cardiomyocytes and fibrosis. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | percentage of left ventricle | Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart) |
|
Baseline to end of study (average 616 days)
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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 | Coronary Disease Patients | Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as a reagent); and DEMRI (gadolinium 0.2 mmol/kg as a reagent). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
The study did not meet its planned sample size of 70 patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip C. Yang | Stanford University | (650) 498-8008 | phillip@stanford.edu |
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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 | Dec 21, 2018 | Jan 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C483739 | EVP 1001-1 |
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Gadolinium-enhanced MRI contrast reagent | Drug | MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg). |
|
|
Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.
| Before,during, and after MEMRI scan (up to 3 hours) |
| Heart Rate | Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute. | Before,during, and after MEMRI scan (up to 3 hours) |
| QT Interval | QT interval during MEMRI scan as a measure of manganese contrast reagent safety. QT is a measurement of heart function that is dependent on heart rate, so QTc is mainly used for diagnosis rather than QT. Normal reference range was considered to be 360-450 milliseconds for this study. | Before and after MEMRI scan (up to 3 hours) |
| Corrected QT (QTc) | Corrected QT (QTc) interval during MEMRI scan as a measure of manganese contrast reagent safety. QTc is a measurement of heart function and is mainly used for diagnosis rather than QT, because QT is dependent on heart rate. Normal reference range was considered to be 360-450 milliseconds for this study. | Before and after MEMRI scan (up to 3 hours) |
| Alanine Aminotransferase (ALT) | ALT levels during MEMRI scan as a measure of manganese contrast reagent safety. ALT is a measurement of liver function. Normal reference range was considered to be <60 U/L for this study. | Before and after MEMRI scan (up to 3 hours) |
| Aspartate Aminotransferase (AST) | AST levels during MEMRI scan as a measure of manganese contrast reagent safety. AST is a measurement of liver function. Normal reference range was considered to be <40 U/L for this study. | Before and after MEMRI scan (up to 3 hours) |
| Alkaline Phosphatase (ALP) | ALP levels during MEMRI scan as a measure of manganese contrast reagent safety. ALP is a measurement of liver function. Normal reference range was considered to be <40-130 U/L for this study. | Before and after MEMRI scan (up to 3 hours) |
| Total Bilirubin | Total bilirubin levels during MEMRI scan as a measure of manganese contrast reagent safety. Total bilirubin is a measurement of liver function. Normal reference range was considered to be <1.4 mg/dL for this study. | Before and after MEMRI scan (up to 3 hours) |
| Creatinine | Creatinine levels during MEMRI scan as a measure of manganese contrast reagent safety. Creatinine is a measurement of kidney function. Normal reference range was considered to be 0.50-1.20 mg/dL for this study. | Before and after MEMRI scan (up to 3 hours) |
| Estimated Glomerular Filtration Rate (eGFR) | eGFR levels during MEMRI scan as a measure of manganese contrast reagent safety. eGFR is a measurement of kidney function. Normal reference range was considered to be >60 ml/min/1.73m^2 for this study. | Before and after MEMRI scan (up to 3 hours) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | mmHg | Before, during, and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | mmHg | Before,during, and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Heart Rate | Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | beats per minute | Before,during, and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | QT Interval | QT interval during MEMRI scan as a measure of manganese contrast reagent safety. QT is a measurement of heart function that is dependent on heart rate, so QTc is mainly used for diagnosis rather than QT. Normal reference range was considered to be 360-450 milliseconds for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | milliseconds | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Corrected QT (QTc) | Corrected QT (QTc) interval during MEMRI scan as a measure of manganese contrast reagent safety. QTc is a measurement of heart function and is mainly used for diagnosis rather than QT, because QT is dependent on heart rate. Normal reference range was considered to be 360-450 milliseconds for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | milliseconds | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Alanine Aminotransferase (ALT) | ALT levels during MEMRI scan as a measure of manganese contrast reagent safety. ALT is a measurement of liver function. Normal reference range was considered to be <60 U/L for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | U/L | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Aspartate Aminotransferase (AST) | AST levels during MEMRI scan as a measure of manganese contrast reagent safety. AST is a measurement of liver function. Normal reference range was considered to be <40 U/L for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | U/L | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Alkaline Phosphatase (ALP) | ALP levels during MEMRI scan as a measure of manganese contrast reagent safety. ALP is a measurement of liver function. Normal reference range was considered to be <40-130 U/L for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | U/L | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Total Bilirubin | Total bilirubin levels during MEMRI scan as a measure of manganese contrast reagent safety. Total bilirubin is a measurement of liver function. Normal reference range was considered to be <1.4 mg/dL for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | mg/dL | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Creatinine | Creatinine levels during MEMRI scan as a measure of manganese contrast reagent safety. Creatinine is a measurement of kidney function. Normal reference range was considered to be 0.50-1.20 mg/dL for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | mg/dL | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | eGFR levels during MEMRI scan as a measure of manganese contrast reagent safety. eGFR is a measurement of kidney function. Normal reference range was considered to be >60 ml/min/1.73m^2 for this study. | Participants who had both MEMRI and DEMRI scans are included in the analysis | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Before and after MEMRI scan (up to 3 hours) |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 14 |
| 33 |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| anxiety | Nervous system disorders | Systematic Assessment |
|
| chest pain | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| flushing | Vascular disorders | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| lip numbness | Nervous system disorders | Systematic Assessment |
|
| malaise | General disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| mild discomfort | General disorders | Systematic Assessment |
|
| mild jaw pain | General disorders | Systematic Assessment |
|
| mild weakness of feet | General disorders | Systematic Assessment |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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