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

Completed · Phase 1/Phase 2

Conditions studied: ISCHEMIC CARDIOMYOPATHY

In brief

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.

Key facts

Study ID

NCT02933034

Run by

Stanford University

People needed

33

Starts

2015-04-01

Expected to finish

2019-02-03

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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