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

• Status: Completed
• Trial end date: 2019-02-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: General Electric
• Treatments: Manganese

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.