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

NCT02933034 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-02-17

Study results available
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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.

Conditions

  • ISCHEMIC CARDIOMYOPATHY

Interventions

DRUG

Manganese-enhanced MRI contrast reagent

MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg).

DRUG

Gadolinium-enhanced MRI contrast reagent

MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg).

Sponsors & Collaborators

Principal Investigators

  • Phillip C Yang, MD · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-02-03
Completion
2019-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02933034 on ClinicalTrials.gov