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

NCT02933034 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 28508
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ISCHEMIC OR CORONARY HEART DISEASE; MYOCARDIAL INFARCTION; MAGNETIC RESONANCE IMAGING; DELAYED GADOLINIUM ENHANCEMENT MRI; MANGANESE-ENHANCED MRI; INFARCT VOLUME/SIZE; ALL CAUSE MORTALITY; VENTRICULAR ARRHYTHMIAS

Outcome Measures

Primary Outcomes (1)

• Infarct Size of MEMRI Versus DEMRI Scans

  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.

  Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)

Secondary Outcomes (11)

• Systolic Blood Pressure

  Before, during, and after MEMRI scan (up to 3 hours)

• Diastolic Blood Pressure

  Before,during, and after MEMRI scan (up to 3 hours)

• Heart Rate

  Before,during, and after MEMRI scan (up to 3 hours)

• QT Interval

  Before and after MEMRI scan (up to 3 hours)

• Corrected QT (QTc)

  Before and after MEMRI scan (up to 3 hours)

Study Arms (1)

Coronary Disease

EXPERIMENTAL

Participant receive 2 cardiac MRI procedures: MEMRI and DEMRI.

Drug: Manganese-enhanced MRI contrast reagent; Drug: Gadolinium-enhanced MRI contrast reagent

Interventions

Manganese-enhanced MRI contrast reagent DRUG

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

Also known as: EVP 1001-1

Coronary Disease

Gadolinium-enhanced MRI contrast reagent DRUG

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

Also known as: GD-DTPA

Coronary Disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Stanford University: lead
• General Electric: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

EVP 1001-1; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Limitations and Caveats

The study did not meet its planned sample size of 70 patients.

Results Point of Contact

• Title: Phillip C. Yang
• Organization: Stanford University

phillip@stanford.edu

(650) 498-8008

Study Officials

• Phillip C Yang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 14, 2016
• Study Start: April 1, 2015
• Primary Completion: February 3, 2019
• Study Completion: February 3, 2019
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)