Clinical trial NCT05107596: Evaluation of CCR2 in Patients Post Myocardial Infarction
Official title: Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Heart Diseases
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who have heart disease as shown in the images
timeFrame: 1 or 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: