Evaluation of CCR2 in Patients Post Myocardial Infarction

November 22, 2022 updated by: Washington University School of Medicine

Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)

To determine the feasibility of 64Cu-DOTA-ECL1i, an investigational PET imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To determine the feasibility of 64Cu-DOTA-ECL1i to detect CCR2+monocytes and macrophages which are cells that are responsible for protecting tissues from foreign substances in the myocardium by PET/MR and PET/CT.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy Volunteers:
  2. Age 21 to 80 years of either sex, any race
  3. Capable of lying still and supine within the PET/CT and PET/MR scanner for 1 hour and follow instructions for breathing protocol during the CT portion
  4. No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
  5. No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes
  6. No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions
  7. Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.

Inflammatory Heart Disease

  1. Age 21 to 80 years of either sex, any race who have suffered a STEMI within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/LVAD
  2. Are clinically stable to undergo imaging with either PET/MR or PET/CT.
  3. Capacity to give written informed consent and ability to follow study procedures
  4. Pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-Cu-DOTA-ECL1i.

Exclusion Criteria:

Healthy volunteers:

  1. Currently enrolled in another study using an investigational drug
  2. Angina
  3. Uncontrolled heart failure
  4. uncontrolled hypertension baseline hypotension below 90/50
  5. Has any condition that in the opinion of the PI or designee that could increase risk to the subject
  6. Is deemed likely to be unable to perform all research procedures
  7. Have contraindications to PET/CT imaging like claustrophobia
  8. Have contraindication to gadolinium
  9. Pregnant or breastfeeding
  10. Currently using recreational drubs
  11. Body weight of more than 300 lbs
  12. Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
  13. currently taking any prescription medications
  14. Presence of an implanted device incompatible with CT or MRI scanning Inflammatory Heart Disease

1) Clinically unstable including post MI angina, uncontrolled heart failure, sever hypertension, hypotension AV block 2) Has any condition that in the opinion of the PI could increase risk to the subject 3) Claustrophobia 4) contraindication to gadolinium contrast 5) Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post ST Elevation Myocardial Infarction/ Heart Attack
Image patients who have had a heart attack
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug
Active Comparator: Sarcoidosis
Image patients who have Sarcoidosis
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug
Active Comparator: Myocarditis
Image patients with Myocarditis
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug
Active Comparator: Cardiomyopathy
Image patients with cardiomyopathy
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug
Active Comparator: Infected Cardiovascular Implantable Electronic Devices
Image patients with cardiovascular implanted medical devices
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug
Active Comparator: Healthy Volunteers
Image healthy volunteers
Drug: 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging
Other Names:
  • Imaging drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have heart disease as shown in the images
Time Frame: 1 or 2 days
PET images will be reconstruction using an iterative algorithm that incorporates resolution recovery, and will be corrected for attenuation using their respective CT or MR data sets
1 or 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2018

Primary Completion (Anticipated)

November 24, 2025

Study Completion (Anticipated)

November 24, 2025

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201807140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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