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Evaluation of CCR2 in Patients Post Myocardial Infarction

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05107596
Collaborator
(none)
90
Enrollment
1
Location
6
Arms
84
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
Actual Study Start Date :
Nov 24, 2018
Anticipated Primary Completion Date :
Nov 24, 2025
Anticipated Study Completion Date :
Nov 24, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants who have heart disease as shown in the images [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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
    2. Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05107596
    Other Study ID Numbers:
    • 201807140
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    Heart Diseases
    Infarction

    Study Results

    No Results Posted as of Nov 4, 2021