Evaluation of CCR2 in Patients Post Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-24

Study Completion Date

2025-11-24

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.

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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.

Conditions

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Heart Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Intervention Type DRUG

Inject PET Radioisotope for imaging

Interventions

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64Cu-DOTA-ECL1i

Inject PET Radioisotope for imaging

Intervention Type DRUG

Other Intervention Names

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Imaging drug

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes