Evaluation of CCR2 in Patients Post Myocardial Infarction

Phase 1

Recruiting

• Conditions: Heart Diseases
• Interventions: Drug: 64Cu-DOTA-ECL1i

• Registration Number: NCT05107596
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2018-11-24
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23
• Primary Completion: 2025-11-24
• Study Completion: 2025-11-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post ST Elevation Myocardial Infarction/ Heart Attack	64Cu-DOTA-ECL1i	Image patients who have had a heart attack
Sarcoidosis	64Cu-DOTA-ECL1i	Image patients who have Sarcoidosis
Myocarditis	64Cu-DOTA-ECL1i	Image patients with Myocarditis
Cardiomyopathy	64Cu-DOTA-ECL1i	Image patients with cardiomyopathy
Infected Cardiovascular Implantable Electronic Devices	64Cu-DOTA-ECL1i	Image patients with cardiovascular implanted medical devices
Healthy Volunteers	64Cu-DOTA-ECL1i	Image healthy volunteers

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States