- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02933034
Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All subjects to be entered must:
- be at least 18 years of age.
- if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- be in stable health based on medical history, examination and tests
Exclusion Criteria:
have a positive pregnancy test (females)
- received an investigational drug or device within 30 days prior to administration of SeeMore
- have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
- have a history of drug abuse or alcoholism
- are taking a digitalis preparation or calcium channel blocker
- have a history of torsades or prolonged QT/QTc interval
- have NYHA Grade IV heart failure
- have abnormal liver function tests or a history of liver disease
- have uncontrolled hypertension (Systolic Blood Pressure > 140 or Diastolic BP > 90 consistently at baseline)
- have abnormal baseline potassium or calcium values or hemoglobin less than 10 g/dl
- are noncompliant or otherwise unlikely to perform as required by the protocol
- have pretest likelihood of CAD for which the requisite number of subjects have been entered
- develop an arrhythmia prior to or during either of the exercise tests; SeeMore should not be administered.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Coronary Disease
Participant receive 2 cardiac MRI procedures: MEMRI and DEMRI.
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MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg).
Other Names:
MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infarct Size of MEMRI Versus DEMRI Scans
Time Frame: Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)
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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.
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Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: Before, during, and after MEMRI scan (up to 3 hours)
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Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety.
Normal reference range: 90-120 mmHg.
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Before, during, and after MEMRI scan (up to 3 hours)
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Diastolic Blood Pressure
Time Frame: Before,during, and after MEMRI scan (up to 3 hours)
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Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety.
Normal reference range: 60-80 mmHg.
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Before,during, and after MEMRI scan (up to 3 hours)
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Heart Rate
Time Frame: Before,during, and after MEMRI scan (up to 3 hours)
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Heart rate during MEMRI scan as a measure of manganese contrast reagent safety.
Normal reference range: 60 and 100 beats per minute.
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Before,during, and after MEMRI scan (up to 3 hours)
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QT Interval
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Corrected QT (QTc)
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Alanine Aminotransferase (ALT)
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Aspartate Aminotransferase (AST)
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Alkaline Phosphatase (ALP)
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Total Bilirubin
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Creatinine
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Before and after MEMRI scan (up to 3 hours)
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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.
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Before and after MEMRI scan (up to 3 hours)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Phillip C Yang, MD, Stanford University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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