Phase 2
Completed N=33
Clinical Trial of Manganese-Enhanced MRI (MEMRI) to Assess Peri-Infarct Injury
ISCHEMIC CARDIOMYOPATHY
Source: ClinicalTrials.gov NCT02933034 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Infarct Size of MEMRI Versus DEMRI Scans — 12.2; 18.9 percentage of left ventricle — p=0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infarct Size of MEMRI Versus DEMRI Scans |
12.2; 18.9 | 0.001 sig |
| SECONDARY Systolic Blood Pressure |
121.8; 160.9; 124.4 | — |
| SECONDARY Diastolic Blood Pressure |
71.8; 92.6; 66.2 | — |
| SECONDARY Heart Rate |
66.3; 82.8; 66.2 | — |
| SECONDARY QT Interval |
414.7; 412.6 | — |
| SECONDARY Corrected QT (QTc) |
435.7; 440.5 | — |
| SECONDARY Alanine Aminotransferase (ALT) |
37.8; 35.1 | — |
| SECONDARY Aspartate Aminotransferase (AST) |
26.1; 25.4 | — |
| SECONDARY Alkaline Phosphatase (ALP) |
80.8; 79.8 | — |
| SECONDARY Total Bilirubin |
0.58; 0.65 | — |
| SECONDARY Creatinine |
1.04; 1.10 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
75.4; 70.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02933034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.