Trial Outcomes & Findings for Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury (NCT NCT02933034)
NCT ID: NCT02933034
Last Updated: 2020-02-17
Results Overview
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.
COMPLETED
PHASE1/PHASE2
33 participants
Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)
2020-02-17
Participant Flow
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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33
|
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Overall Study
Received Both MEMRI and DEMRI Scans
|
24
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
|
9
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
Baseline characteristics by cohort
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Age, Continuous
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63.0 years
STANDARD_DEVIATION 7.6 • n=93 Participants
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Sex: Female, Male
Female
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3 Participants
n=93 Participants
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Sex: Female, Male
Male
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21 Participants
n=93 Participants
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Race/Ethnicity, Customized
Caucasian
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11 Participants
n=93 Participants
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|
Race/Ethnicity, Customized
Asian
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4 Participants
n=93 Participants
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Race/Ethnicity, Customized
South Asian
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6 Participants
n=93 Participants
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Race/Ethnicity, Customized
Latino
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3 Participants
n=93 Participants
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Region of Enrollment
United States
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24 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Infarct Size of MEMRI Versus DEMRI Scans
MEMRI
|
12.2 percentage of left ventricle
Standard Deviation 7.3
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Infarct Size of MEMRI Versus DEMRI Scans
DEMRI
|
18.9 percentage of left ventricle
Standard Deviation 11.9
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SECONDARY outcome
Timeframe: Before, during, and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Systolic Blood Pressure
Baseline
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121.8 mmHg
Standard Deviation 16.4
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Systolic Blood Pressure
During MRI
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160.9 mmHg
Standard Deviation 24.4
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Systolic Blood Pressure
Post MRI
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124.4 mmHg
Standard Deviation 18.3
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SECONDARY outcome
Timeframe: Before,during, and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Diastolic Blood Pressure
Baseline
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71.8 mmHg
Standard Deviation 9.1
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Diastolic Blood Pressure
During MRI
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92.6 mmHg
Standard Deviation 10.8
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Diastolic Blood Pressure
Post MRI
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66.2 mmHg
Standard Deviation 10.0
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SECONDARY outcome
Timeframe: Before,during, and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Heart Rate
Baseline
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66.3 beats per minute
Standard Deviation 9.9
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Heart Rate
During MRI
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82.8 beats per minute
Standard Deviation 15.1
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Heart Rate
Post MRI
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66.2 beats per minute
Standard Deviation 10.0
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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QT Interval
Baseline
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414.7 milliseconds
Standard Deviation 40.1
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QT Interval
Post MRI
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412.6 milliseconds
Standard Deviation 38.2
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
|
|---|---|
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Corrected QT (QTc)
Baseline
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435.7 milliseconds
Standard Deviation 34.5
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Corrected QT (QTc)
Post MRI
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440.5 milliseconds
Standard Deviation 37.3
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Alanine Aminotransferase (ALT)
Baseline
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37.8 U/L
Standard Deviation 18.4
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Alanine Aminotransferase (ALT)
Post MRI
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35.1 U/L
Standard Deviation 12.6
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Aspartate Aminotransferase (AST)
Baseline
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26.1 U/L
Standard Deviation 12.4
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Aspartate Aminotransferase (AST)
Post MRI
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25.4 U/L
Standard Deviation 9.1
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Alkaline Phosphatase (ALP)
Baseline
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80.8 U/L
Standard Deviation 21.9
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Alkaline Phosphatase (ALP)
Post MRI
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79.8 U/L
Standard Deviation 26.7
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Total Bilirubin
Baseline
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0.58 mg/dL
Standard Deviation 0.21
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Total Bilirubin
Post MRI
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0.65 mg/dL
Standard Deviation 0.30
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Creatinine
Baseline
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1.04 mg/dL
Standard Deviation 0.23
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Creatinine
Post MRI
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1.10 mg/dL
Standard Deviation 0.19
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SECONDARY outcome
Timeframe: Before and after MEMRI scan (up to 3 hours)Population: Participants who had both MEMRI and DEMRI scans are included in the analysis
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.
Outcome measures
| Measure |
Coronary Disease Patients
n=24 Participants
Participants receive 2 cardiac MRI procedures: MEMRI (manganese 0.28 mL/kg as reagent); and DEMRI (gadolinium 0.2 mmol/kg as reagent).
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|---|---|
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Estimated Glomerular Filtration Rate (eGFR)
Pre MRI
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75.4 mL/min/1.73m^2
Standard Deviation 20.5
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Estimated Glomerular Filtration Rate (eGFR)
Post MRI
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70.5 mL/min/1.73m^2
Standard Deviation 16.0
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Adverse Events
Coronary Disease Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coronary Disease Patients
n=33 participants at risk
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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Gastrointestinal disorders
abdominal discomfort
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3.0%
1/33 • Baseline to end of study (average 616 days)
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Gastrointestinal disorders
abdominal pain
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9.1%
3/33 • Baseline to end of study (average 616 days)
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Nervous system disorders
anxiety
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3.0%
1/33 • Baseline to end of study (average 616 days)
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General disorders
chest pain
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6.1%
2/33 • Baseline to end of study (average 616 days)
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Gastrointestinal disorders
constipation
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3.0%
1/33 • Baseline to end of study (average 616 days)
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General disorders
fatigue
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6.1%
2/33 • Baseline to end of study (average 616 days)
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Vascular disorders
flushing
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27.3%
9/33 • Baseline to end of study (average 616 days)
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Metabolism and nutrition disorders
hypoglycemia
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3.0%
1/33 • Baseline to end of study (average 616 days)
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Nervous system disorders
lip numbness
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3.0%
1/33 • Baseline to end of study (average 616 days)
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General disorders
malaise
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3.0%
1/33 • Baseline to end of study (average 616 days)
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Gastrointestinal disorders
nausea
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9.1%
3/33 • Baseline to end of study (average 616 days)
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General disorders
mild discomfort
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3.0%
1/33 • Baseline to end of study (average 616 days)
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General disorders
mild jaw pain
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3.0%
1/33 • Baseline to end of study (average 616 days)
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General disorders
mild weakness of feet
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3.0%
1/33 • Baseline to end of study (average 616 days)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place