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Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury

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ClinicalTrials.gov Identifier: NCT02933034
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Phillip C. Yang, MD, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition ISCHEMIC CARDIOMYOPATHY
Interventions Drug: Manganese-enhanced MRI contrast reagent
Drug: Gadolinium-enhanced MRI contrast reagent
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 33
Received Both MEMRI and DEMRI Scans 24
Completed 24
Not Completed 9
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Participants who had both MEMRI and DEMRI scans were considered evaluable for baseline characteristics
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
63.0  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
3
  12.5%
Male
21
  87.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Caucasian
11
  45.8%
Asian
4
  16.7%
South Asian
6
  25.0%
Latino
3
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Infarct Size of MEMRI Versus DEMRI Scans
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: percentage of left ventricle
MEMRI 12.2  (7.3)
DEMRI 18.9  (11.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coronary Disease Patients
Comments Comparison of infarct size using MEMRI versus DEMRI scan
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg.
Time Frame Before, during, and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 121.8  (16.4)
During MRI 160.9  (24.4)
Post MRI 124.4  (18.3)
3.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.
Time Frame Before,during, and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 71.8  (9.1)
During MRI 92.6  (10.8)
Post MRI 66.2  (10.0)
4.Secondary Outcome
Title Heart Rate
Hide Description Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute.
Time Frame Before,during, and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline 66.3  (9.9)
During MRI 82.8  (15.1)
Post MRI 66.2  (10.0)
5.Secondary Outcome
Title QT Interval
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 414.7  (40.1)
Post MRI 412.6  (38.2)
6.Secondary Outcome
Title Corrected QT (QTc)
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 435.7  (34.5)
Post MRI 440.5  (37.3)
7.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline 37.8  (18.4)
Post MRI 35.1  (12.6)
8.Secondary Outcome
Title Aspartate Aminotransferase (AST)
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline 26.1  (12.4)
Post MRI 25.4  (9.1)
9.Secondary Outcome
Title Alkaline Phosphatase (ALP)
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline 80.8  (21.9)
Post MRI 79.8  (26.7)
10.Secondary Outcome
Title Total Bilirubin
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 0.58  (0.21)
Post MRI 0.65  (0.30)
11.Secondary Outcome
Title Creatinine
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 1.04  (0.23)
Post MRI 1.10  (0.19)
12.Secondary Outcome
Title Estimated Glomerular Filtration Rate (eGFR)
Hide Description 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.
Time Frame Before and after MEMRI scan (up to 3 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both MEMRI and DEMRI scans are included in the analysis
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description:
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
Pre MRI 75.4  (20.5)
Post MRI 70.5  (16.0)
Time Frame Baseline to end of study (average 616 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coronary Disease Patients
Hide Arm/Group Description 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).
All-Cause Mortality
Coronary Disease Patients
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Serious Adverse Events
Coronary Disease Patients
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coronary Disease Patients
Affected / at Risk (%)
Total   14/33 (42.42%) 
Gastrointestinal disorders   
abdominal discomfort   1/33 (3.03%) 
abdominal pain   3/33 (9.09%) 
constipation   1/33 (3.03%) 
nausea   3/33 (9.09%) 
General disorders   
chest pain   2/33 (6.06%) 
fatigue   2/33 (6.06%) 
malaise   1/33 (3.03%) 
mild discomfort   1/33 (3.03%) 
mild jaw pain   1/33 (3.03%) 
mild weakness of feet   1/33 (3.03%) 
Metabolism and nutrition disorders   
hypoglycemia   1/33 (3.03%) 
Nervous system disorders   
anxiety   1/33 (3.03%) 
lip numbness   1/33 (3.03%) 
Vascular disorders   
flushing   9/33 (27.27%) 
Indicates events were collected by systematic assessment
The study did not meet its planned sample size of 70 patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Phillip C. Yang
Organization: Stanford University
Phone: (650) 498-8008
EMail: phillip@stanford.edu
Layout table for additonal information
Responsible Party: Phillip C. Yang, MD, Stanford University
ClinicalTrials.gov Identifier: NCT02933034    
Other Study ID Numbers: 28508
First Submitted: October 11, 2016
First Posted: October 14, 2016
Results First Submitted: February 1, 2020
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020