Evaluation of CCR2 in Patients Post Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Drug: 64Cu-DOTA-ECL1i


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers: Age 21 to 80 years of either sex, any race 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 No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol. Inflammatory Heart Disease 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 Are clinically stable to undergo imaging with either PET/MR or PET/CT. Capacity to give written informed consent and ability to follow study procedures 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: Currently enrolled in another study using an investigational drug Angina Uncontrolled heart failure uncontrolled hypertension baseline hypotension below 90/50 Has any condition that in the opinion of the PI or designee that could increase risk to the subject Is deemed likely to be unable to perform all research procedures Have contraindications to PET/CT imaging like claustrophobia Have contraindication to gadolinium Pregnant or breastfeeding Currently using recreational drubs Body weight of more than 300 lbs Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes currently taking any prescription medications 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who have heart disease as shown in the images | 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 |