Evaluation of CCR2 in Patients Post Myocardial Infarction

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107596
• Other study ID #: 201807140
• Status: Recruiting
• Phase: Phase 1
• Start date: November 24, 2018
• Est. completion date: November 24, 2025

Study information

• Verified date: November 2022
• Source: Washington University School of Medicine
• Contact: Kitty D Harrison, BSN, RN
• Phone: 314-747-0183
• Email: kittydharrison[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 24, 2025
• Est. primary completion date: November 24, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Infarction
• Myocardial Infarction

Intervention

Drug:
• 64Cu-DOTA-ECL1i
Inject PET Radioisotope for imaging

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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